Recall archive / FDA device enforcement

Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MIN... — FDA record Z-1079-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 17, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI LITHOTOMY p. MAJOR CDS-1 q. MINOR CDS-1 r. VASCULAR CDS-4 s. SEPTOPLASTY CDS t. DENTAL CDS u. MINOR GENERAL CDS v. CUH UROLOGY LITHOTOMY CDS w. CUH UROLOGY OPEN CDS x. CUH LIVER TRANSPLANT CDS y. THORACOTOMY CDS z. XI THORACIC ROBOTIC CDS aa. GENERAL CDS bb. THORACIC CDS cc. MINOR PROCEDURE dd. EXTREMITY CDS ee. DOUBLE BASIN CDS ff. PEDIATRIC gg. P.V.STARTER TRAY hh. CV PACK ii. MINOR GENERAL-LF jj. VASCULAR PACK-LF kk. UROLOGY PACK ll. MINOR LINEN PACK-LF mm. ABDOMINAL PACK-LF nn. MINOR SURGICAL SETUP PACK-LF oo. MINOR GENERAL PACK-LF pp. MAJOR ABDOMINAL PACK-LF qq. MINOR VASCULAR PACK-LF rr. MAJOR BASIN PACK-LF ss. DAVINCI PACK-LF tt. MINOR ENT HARPER PACK-LF uu. CHOM START UP PACK-LF vv. MINOR HARPER PACK-LF ww. MAJOR ENT HARPER PACK-LF xx. THROMBECTOMY HARPER PACK-LF yy. PENILE PROSTHESIS HARPER PK-LF zz. RECONSTRUCTIVE PACK-LF aaa. CUSTOM COLIC PACK bbb. MAJOR PACK ccc. ROBOTIC PACK ddd. MINOR PACK eee. MINOR PACK-LF fff. CT THORACIC PACK ggg. KIDNEY TRANSPLANT PACK-LF hhh. DAVINCI ROBOTIC PACK iii. MAJOR UNIVERSAL PACK-LF jjj. BASIC SETUP PACK-LF kkk. BASIC ABDOMINAL PACK-LF lll. PENILE IMPLANT PACK-LF mmm. VALVE UNIV OF CINN PACK-LF nnn. CABG UNIVERSITY HOSP PACK-LF ooo. AAA - UNIV ppp. LIVER TRANSPLNT UNIV CI PK-LF qqq. AV FISTULA PACK-LF rrr. MAJOR PACK-LF sss. MINOR SNGL BASIN PACK-LF ttt. MAJOR BASIN PACK-LF uuu. MAJOR PACK L-F vvv. PEDIATRIC PACK www. BASIC PACK-LF xxx. BASIC PACK-LF yyy. MAJOR PACK-LF zzz. MAJOR PACK aaaa. MINOR PACK bbbb. UPPER EXTREMITY PACK-LF cccc. MAJOR PACK-LF dddd. DR PALEY ILIZAROV PACK-LF eeee. MAJOR PACK ffff. BASIC PACK-LF gggg. MAJOR PACK hhhh. MAJOR LITHOTOMY PACK iiii. MAJOR LITHOTOMY PACK-LF jjjj. MAJOR PACK kkkk. MAJOR PACK llll. MAJOR LITHOTOMY PACK mmmm. AMC MINOR PACK-LF nnnn. MINOR PACK-LF oooo. MAJOR LITHOTOMY PACK-LF pppp. MAJOR PACK qqqq. MAJOR PACK-LF rrrr. MINOR GENERAL PACK ssss. MINOR ACUTE PACK-LF tttt. BASIC PACK uuuu. GENERAL PACK-LF vvvv. MAJOR BASIN PACK-LF wwww. VASCULAR SSC PACK xxxx. DAVINCI PACK-LF yyyy. SINGLE BASIN PLUS 1-LF zzzz. CUSTOM LID PACK-LF aaaaa. BARIATRIC PACK-LF bbbbb. SINGLE BASIN PLUS 4-LF ccccc. MINOR OR SET-UP PACK-LF ddddd. MINOR LAP PACK eeeee. TRAUMA PACK-LF fffff. MAJOR LITHOTOMY PACK-LF ggggg. MINOR LITHOTOMY PACK-LF hhhhh. MAJOR PROCEDURE PACK-LF iiiii. MINOR PROCEDURE PACK-LF jjjjj. DEEP BRAIN STIMULATION PACK kkkkk. VOORHEES SUMMIT T AND A PK-LF lllll. BASIC PACK-LF mmmmm. ASCI BASIC PACK nnnnn. GASTRIC BY PASS PACK-LF ooooo. MINOR PACK-LF ppppp. MAJOR SET-LF qqqqq. BASIC PACK-LF rrrrr. TRMC- GENERAL SURGERY PACK sssss. TRMC- PERI GYN PACK ttttt. PEDIATRIC PACK uuuuu. PENILE PROSTHESIS PK W/AUX vvvvv. ACCOLA AVR/MVR COMPONENT PACK wwwww. ACCOLA ...
Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Classification: Class II
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 62,930 cases (215,456 units)
Agency-reported status: Ongoing
Source record identifier: Z-1079-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	a. BASIN SET-UP PACK, Item Number: BAD079F, Case UDI/GTIN: 40889942614135, Unit UDI/GTIN: 10889942614134, Lot Number: 22IBR514; b. LAP CHOLE CDS, Item Number: CDS860230D, Case UDI/GTIN: 40888277749376, Unit UDI/GTIN: 10888277749375, Lot Number: 22JMG555; c. MAJOR CDS, Item Number: CDS980178G, Case UDI/GTIN: 40888277906458, Unit UDI/GTIN: 10888277906457, Lot Number: 22JMG570,22JMC877; d. UROLOGY MINOR CDS, Item Number: CDS980371L, Case UDI/GTIN: 40195327050956, Unit UDI/GTIN: 10195327050955, Lot Number: 22HBU946; e. UROLOGY MAJOR CDS, Item Number: CDS980383O, Case UDI/GTIN: 40195327251193, Unit UDI/GTIN: 10195327251192, Lot Number: 22JBV588; f. SINGLE BASIC CDS, Item Number: CDS980389O, Case UDI/GTIN: 40195327231607, Unit UDI/GTIN: 10195327231606, Lot Number: 22JMF540; g. ORGAN RECOVERY CDS, Item Number: CDS980556F, Case UDI/GTIN: 40888277793836, Unit UDI/GTIN: 10888277793835, Lot Number: 22JBO588,22IBV960; h. GENERAL ABD CDS, Item Number: CDS980628I, Case UDI/GTIN: 40193489540667, Unit UDI/GTIN: 10193489540666, Lot Number: 22IMG415; i. BURN CDS, Item Number: CDS980629J, Case UDI/GTIN: 40193489540377, Unit UDI/GTIN: 10193489540376, Lot Number: 22JMG578; j. MINOR, Item Number: CDS980749G, Case UDI/GTIN: 40888277977496, Unit UDI/GTIN: 10888277977495, Lot Number: 22IBE725; k. MAJOR VASCULAR, Item Number: CDS980752I, Case UDI/GTIN: 40889942428541, Unit UDI/GTIN: 10889942428540, Lot Number: 22JBU157,22JBB126; l. BASIC CORE CDS, Item Number: CDS982062F, Case UDI/GTIN: 40193489648431, Unit UDI/GTIN: 10193489648430, Lot Number: 22JBP662,22JBO884; m. ROBOTIC PROCEDURE, Item Number: CDS982128O, Case UDI/GTIN: 40193489775533, Unit UDI/GTIN: 10193489775532, Lot Number: 22JBO084,22JBJ689; n. MAJOR VASCULAR CDS, Item Number: CDS982613G, Case UDI/GTIN: 40888277737076, Unit UDI/GTIN: 10888277737075, Lot Number: 22JBK713; o. PEDI LITHOTOMY, Item Number: CDS982718K, Case UDI/GTIN: 40193489418201, Unit UDI/GTIN: 10193489418200, Lot Number: 22JBR860,22JBK829,22IBH995; p. MAJOR CDS-1, Item Number: CDS982898G, Case UDI/GTIN: 40889942217411, Unit UDI/GTIN: 10889942217410, Lot Number: 22IBO658,22IBN353,22IBF023; q. MINOR CDS-1, Item Number: CDS982899F, Case UDI/GTIN: 40889942216933, Unit UDI/GTIN: 10889942216932, Lot Number: 22KBD131,22IBU676,22IBD867; r. VASCULAR CDS-4, Item Number: CDS983003F, Case UDI/GTIN: 40889942217459, Unit UDI/GTIN: 10889942217458, Lot Number: 22JBG357,22IBQ259; s. SEPTOPLASTY CDS, Item Number: CDS983100C, Case UDI/GTIN: 40889942926764, Unit UDI/GTIN: 10889942926763, Lot Number: 22JBB204; t. DENTAL CDS, Item Number: CDS983103C, Case UDI/GTIN: 40889942926672, Unit UDI/GTIN: 10889942926671, Lot Number: 22JBR350,22JBO090,22JBJ684; u. MINOR GENERAL CDS, Item Number: CDS983109F, Case UDI/GTIN: 40193489202343, Unit UDI/GTIN: 10193489202342, Lot Number: 22KBF514,22JBD721; v. CUH UROLOGY LITHOTOMY CDS, Item Number: CDS983180L, Case UDI/GTIN: 40195327179626, Unit UDI/GTIN: 10195327179625, Lot Number: 22JBM355; w. CUH UROLOGY OPEN CDS, Item Number: CDS983191G, Case UDI/GTIN: 40888277781673, Unit UDI/GTIN: 10888277781672, Lot Number: 22JBM356,22IBC756; x. CUH LIVER TRANSPLANT CDS, Item Number: CDS983654K, Case UDI/GTIN: 40195327164561, Unit UDI/GTIN: 10195327164560, Lot Number: 22JBO589; y. THORACOTOMY CDS, Item Number: CDS983692K, Case UDI/GTIN: 40193489953573, Unit UDI/GTIN: 10193489953572, Lot Number: 22JBR359; z. XI THORACIC ROBOTIC CDS, Item Number: CDS984338K, Case UDI/GTIN: 40195327221240, Unit UDI/GTIN: 10195327221249, Lot Number: 22KBG387; aa. GENERAL CDS, Item Number: CDS984628L, Case UDI/GTIN: 40195327070763, Unit UDI/GTIN: 10195327070762, Lot Number: 22JBH835,22IBU580; bb. THORACIC CDS, Item Number: CDS984637F, Case UDI/GTIN: 40193489861441, Unit UDI/GTIN: 10193489861440, Lot Number: 22IBF812,22IBD913,22IBA427; cc. MINOR PROCEDURE, Item Number: CDS984897J, Case UDI/GTIN: 40193489983846, Unit UDI/GTIN: 10193489983845, Lot Number: 22JBC519; dd. EXTREMITY CDS, Item Number: CDS985203B, Case UDI/GTIN: 40889942941613, Unit UDI/GTIN: 10889942941612, Lot Number: 22JBE301,22JBA666; ee. DOUBLE BASIN CDS, Item Number: CDS985205B, Case UDI/GTIN: 40889942941620, Unit UDI/GTIN: 10889942941629, Lot Number: 22KBH397; ff. PEDIATRIC, Item Number: CDS985465D, Case UDI/GTIN: 40195327090785, Unit UDI/GTIN: 10195327090784, Lot Number: 22IDA937; gg. P.V.STARTER TRAY, Item Number: CV6222T, Case UDI/GTIN: 40193489314626, Unit UDI/GTIN: 10193489314625, Lot Number: 22JLA509,22ILA422; hh. CV PACK, Item Number: CVT079R, Case UDI/GTIN: 40193489215619, Unit UDI/GTIN: 10193489215618, Lot Number: 22JBJ591; ii. MINOR GENERAL-LF, Item Number: DYNJ00199D, Case UDI/GTIN: 40884389429991, Unit UDI/GTIN: 10884389429990, Lot Number: 22IBN962; jj. VASCULAR PACK-LF, Item Number: DYNJ00203D, Case UDI/GTIN: 40888277206459, Unit UDI/GTIN: 10888277206458, Lot Number: 22IBT212; kk. UROLOGY PACK, Item Number: DYNJ01038J, Case UDI/GTIN: 40889942864820, Unit UDI/GTIN: 10889942864829, Lot Number: 22JDA606; ll. MINOR LINEN PACK-LF, Item Number: DYNJ0112530T, Case UDI/GTIN: 40195327115785, Unit UDI/GTIN: 10195327115784, Lot Number: 22JMI192; mm. ABDOMINAL PACK-LF, Item Number: DYNJ0149594F, Case UDI/GTIN: 40193489730228, Unit UDI/GTIN: 10193489730227, Lot Number: 22IMI490,22HME197; nn. MINOR SURGICAL SETUP PACK-LF, Item Number: DYNJ0151516B, Case UDI/GTIN: 40889942216346, Unit UDI/GTIN: 10889942216345, Lot Number: 22HDC003; oo. MINOR GENERAL PACK-LF, Item Number: DYNJ0159495C, Case UDI/GTIN: 40889942214427, Unit UDI/GTIN: 10889942214426, Lot Number: 22IDB673; pp. MAJOR ABDOMINAL PACK-LF, Item Number: DYNJ0159548D, Case UDI/GTIN: 40193489207447, Unit UDI/GTIN: 10193489207446, Lot Number: 22JDA012,22HDB747; qq. MINOR VASCULAR PACK-LF, Item Number: DYNJ0160151A, Case UDI/GTIN: 40889942051725, Unit UDI/GTIN: 10889942051724, Lot Number: 22JDC189,22IDB468; rr. MAJOR BASIN PACK-LF, Item Number: DYNJ0160289A, Case UDI/GTIN: 40889942051749, Unit UDI/GTIN: 10889942051748, Lot Number: 22JDC198; ss. DAVINCI PACK-LF, Item Number: DYNJ0160306D, Case UDI/GTIN: 40193489521352, Unit UDI/GTIN: 10193489521351, Lot Number: 22JDC152,22IDA021; tt. MINOR ENT HARPER PACK-LF, Item Number: DYNJ0160700D, Case UDI/GTIN: 40193489205597, Unit UDI/GTIN: 10193489205596, Lot Number: 22IDC074,22IDA779,22IDA853,22IDA192,22HDB958; uu. CHOM START UP PACK-LF, Item Number: DYNJ0161358B, Case UDI/GTIN: 40889942213260, Unit UDI/GTIN: 10889942213269, Lot Number: 22JDC165; vv. MINOR HARPER PACK-LF, Item Number: DYNJ0161694D, Case UDI/GTIN: 40889942219620, Unit UDI/GTIN: 10889942219629, Lot Number: 22IDB272,22IDA785; ww. MAJOR ENT HARPER PACK-LF, Item Number: DYNJ0161710F, Case UDI/GTIN: 40193489205573, Unit UDI/GTIN: 10193489205572, Lot Number: 22JDC154,22IDA194; xx. THROMBECTOMY HARPER PACK-LF, Item Number: DYNJ0161832D, Case UDI/GTIN: 40193489205559, Unit UDI/GTIN: 10193489205558, Lot Number: 22IDB848,22IDA001; yy. PENILE PROSTHESIS HARPER PK-LF, Item Number: DYNJ0161854C, Case UDI/GTIN: 40193489205429, Unit UDI/GTIN: 10193489205428, Lot Number: 22JDA162; zz. RECONSTRUCTIVE PACK-LF, Item Number: DYNJ0185115N, Case UDI/GTIN: 40193489376389, Unit UDI/GTIN: 10193489376388, Lot Number: 22HME609; aaa. CUSTOM COLIC PACK, Item Number: DYNJ0190097D, Case UDI/GTIN: 40193489357500, Unit UDI/GTIN: 10193489357509, Lot Number: 22IMB627; bbb. MAJOR PACK, Item Number: DYNJ01922K, Case UDI/GTIN: 40193489775564, Unit UDI/GTIN: 10193489775563, Lot Number: 22HBF615; ccc. ROBOTIC PACK, Item Number: DYNJ02314G, Case UDI/GTIN: 40193489669696, Unit UDI/GTIN: 10193489669695, Lot Number: 22IMD665; ddd. MINOR PACK, Item Number: DYNJ02480D, Case UDI/GTIN: 40193489775625, Unit UDI/GTIN: 10193489775624, Lot Number: 22JBO134; eee. MINOR PACK-LF, Item Number: DYNJ0259893S, Case UDI/GTIN: 40193489506960, Unit UDI/GTIN: 10193489506969, Lot Number: 22IMF443; fff. CT THORACIC PACK, Item Number: DYNJ0271168Q, Case UDI/GTIN: 40195327089277, Unit UDI/GTIN: 10195327089276, Lot Number: 22JBK798,22IBF123; ggg. KIDNEY TRANSPLANT PACK-LF, Item Number: DYNJ0282000U, Case UDI/GTIN: 40195327088485, Unit UDI/GTIN: 10195327088484, Lot Number: 22JDB414,22JDA237; hhh. DAVINCI ROBOTIC PACK, Item Number: DYNJ02857C, Case UDI/GTIN: 40888277743657, Unit UDI/GTIN: 10888277743656, Lot Number: 22IMC528; iii. MAJOR UNIVERSAL PACK-LF, Item Number: DYNJ0341046F, Case UDI/GTIN: 40193489735094, Unit UDI/GTIN: 10193489735093, Lot Number: 22IME563,22HMC086; jjj. BASIC SETUP PACK-LF, Item Number: DYNJ0371494M, Case UDI/GTIN: 40889942492955, Unit UDI/GTIN: 10889942492954, Lot Number: 22IMH376; kkk. BASIC ABDOMINAL PACK-LF, Item Number: DYNJ0374119M, Case UDI/GTIN: 40889942902133, Unit UDI/GTIN: 10889942902132, Lot Number: 22JBY441,22JBO082,22HBT994; lll. PENILE IMPLANT PACK-LF, Item Number: DYNJ0374945M, Case UDI/GTIN: 40193489466721, Unit UDI/GTIN: 10193489466720, Lot Number: 22HBY419; mmm. VALVE UNIV OF CINN PACK-LF, Item Number: DYNJ0375673L, Case UDI/GTIN: 40193489544122, Unit UDI/GTIN: 10193489544121, Lot Number: 22IBL136; nnn. CABG UNIVERSITY HOSP PACK-LF, Item Number: DYNJ0375705L, Case UDI/GTIN: 40193489544139, Unit UDI/GTIN: 10193489544138, Lot Number: 22JBO601; ooo. AAA - UNIV, Item Number: DYNJ0375731N, Case UDI/GTIN: 40193489423229, Unit UDI/GTIN: 10193489423228, Lot Number: 22JBI941; ppp. LIVER TRANSPLNT UNIV CI PK-LF, Item Number: DYNJ0376001O, Case UDI/GTIN: 40193489544207, Unit UDI/GTIN: 10193489544206, Lot Number: 22IBG362; qqq. AV FISTULA PACK-LF, Item Number: DYNJ0376614I, Case UDI/GTIN: 40889942419662, Unit UDI/GTIN: 10889942419661, Lot Number: 22JMH867; rrr. MAJOR PACK-LF, Item Number: DYNJ0378191M, Case UDI/GTIN: 40889942469339, Unit UDI/GTIN: 10889942469338, Lot Number: 22HME980; sss. MINOR SNGL BASIN PACK-LF, Item Number: DYNJ0379441D, Case UDI/GTIN: 40193489348058, Unit UDI/GTIN: 10193489348057, Lot Number: 22IMB634; ttt. MAJOR BASIN PACK-LF, Item Number: DYNJ0381555J, Case UDI/GTIN: 40193489475365, Unit UDI/GTIN: 10193489475364, Lot Number: 22JBO287; uuu. MAJOR PACK L-F, Item Number: DYNJ0382730L, Case UDI/GTIN: 40193489899291, Unit UDI/GTIN: 10193489899290, Lot Number: 22JMG763,22IMG639; vvv. PEDIATRIC PACK, Item Number: DYNJ0382751P, Case UDI/GTIN: 40193489899307, Unit UDI/GTIN: 10193489899306, Lot Number: 22JME325; www. BASIC PACK-LF, Item Number: DYNJ0382788P, Case UDI/GTIN: 40193489899314, Unit UDI/GTIN: 10193489899313, Lot Number: 22JMA518,22IMB261; xxx. BASIC PACK-LF, Item Number: DYNJ0387695D, Case UDI/GTIN: 40195327270149, Unit UDI/GTIN: 10195327270148, Lot Number: 22JMI200; yyy. MAJOR PACK-LF, Item Number: DYNJ0400297K, Case UDI/GTIN: 40889942402374, Unit UDI/GTIN: 10889942402373, Lot Number: 22JMG608,22IMH378; zzz. MAJOR PACK, Item Number: DYNJ04379K, Case UDI/GTIN: 40193489552011, Unit UDI/GTIN: 10193489552010, Lot Number: 22IMI201,22HME526; aaaa. MINOR PACK, Item Number: DYNJ04380J, Case UDI/GTIN: 40193489552028, Unit UDI/GTIN: 10193489552027, Lot Number: 22JMC853,22JMC970; bbbb. UPPER EXTREMITY PACK-LF, Item Number: DYNJ04438L, Case UDI/GTIN: 40888277753380, Unit UDI/GTIN: 10888277753389, Lot Number: 22JMB708; cccc. MAJOR PACK-LF, Item Number: DYNJ04443L, Case UDI/GTIN: 40193489554183, Unit UDI/GTIN: 10193489554182, Lot Number: 22JMC971,22JMB709,22HMC674; dddd. DR PALEY ILIZAROV PACK-LF, Item Number: DYNJ0445416N, Case UDI/GTIN: 40193489899260, Unit UDI/GTIN: 10193489899269, Lot Number: 22HBT955,22HBT622; eeee. MAJOR PACK, Item Number: DYNJ04459L, Case UDI/GTIN: 40195327032389, Unit UDI/GTIN: 10195327032388, Lot Number: 22JMC972,22IMB642; ffff. BASIC PACK-LF, Item Number: DYNJ04514M, Case UDI/GTIN: 40888277744067, Unit UDI/GTIN: 10888277744066, Lot Number: 22JMC973; gggg. MAJOR PACK, Item Number: DYNJ04524F, Case UDI/GTIN: 40888277744234, Unit UDI/GTIN: 10888277744233, Lot Number: 22JMH182; hhhh. MAJOR LITHOTOMY PACK, Item Number: DYNJ04541M, Case UDI/GTIN: 40193489553544, Unit UDI/GTIN: 10193489553543, Lot Number: 22JMA298; iiii. MAJOR LITHOTOMY PACK-LF, Item Number: DYNJ04602I, Case UDI/GTIN: 40193489552714, Unit UDI/GTIN: 10193489552713, Lot Number: 22HMF017; jjjj. MAJOR PACK, Item...

Label field

Details supplied by the agency

Lot, code or applicability

a. BASIN SET-UP PACK, Item Number: BAD079F, Case UDI/GTIN: 40889942614135, Unit UDI/GTIN: 10889942614134, Lot Number: 22IBR514; b. LAP CHOLE CDS, Item Number: CDS860230D, Case UDI/GTIN: 40888277749376, Unit UDI/GTIN: 10888277749375, Lot Number: 22JMG555; c. MAJOR CDS, Item Number: CDS980178G, Case UDI/GTIN: 40888277906458, Unit UDI/GTIN: 10888277906457, Lot Number: 22JMG570,22JMC877; d. UROLOGY MINOR CDS, Item Number: CDS980371L, Case UDI/GTIN: 40195327050956, Unit UDI/GTIN: 10195327050955, Lot Number: 22HBU946; e. UROLOGY MAJOR CDS, Item Number: CDS980383O, Case UDI/GTIN: 40195327251193, Unit UDI/GTIN: 10195327251192, Lot Number: 22JBV588; f. SINGLE BASIC CDS, Item Number: CDS980389O, Case UDI/GTIN: 40195327231607, Unit UDI/GTIN: 10195327231606, Lot Number: 22JMF540; g. ORGAN RECOVERY CDS, Item Number: CDS980556F, Case UDI/GTIN: 40888277793836, Unit UDI/GTIN: 10888277793835, Lot Number: 22JBO588,22IBV960; h. GENERAL ABD CDS, Item Number: CDS980628I, Case UDI/GTIN: 40193489540667, Unit UDI/GTIN: 10193489540666, Lot Number: 22IMG415; i. BURN CDS, Item Number: CDS980629J, Case UDI/GTIN: 40193489540377, Unit UDI/GTIN: 10193489540376, Lot Number: 22JMG578; j. MINOR, Item Number: CDS980749G, Case UDI/GTIN: 40888277977496, Unit UDI/GTIN: 10888277977495, Lot Number: 22IBE725; k. MAJOR VASCULAR, Item Number: CDS980752I, Case UDI/GTIN: 40889942428541, Unit UDI/GTIN: 10889942428540, Lot Number: 22JBU157,22JBB126; l. BASIC CORE CDS, Item Number: CDS982062F, Case UDI/GTIN: 40193489648431, Unit UDI/GTIN: 10193489648430, Lot Number: 22JBP662,22JBO884; m. ROBOTIC PROCEDURE, Item Number: CDS982128O, Case UDI/GTIN: 40193489775533, Unit UDI/GTIN: 10193489775532, Lot Number: 22JBO084,22JBJ689; n. MAJOR VASCULAR CDS, Item Number: CDS982613G, Case UDI/GTIN: 40888277737076, Unit UDI/GTIN: 10888277737075, Lot Number: 22JBK713; o. PEDI LITHOTOMY, Item Number: CDS982718K, Case UDI/GTIN: 40193489418201, Unit UDI/GTIN: 10193489418200, Lot Number: 22JBR860,22JBK829,22IBH995; p. MAJOR CDS-1, Item Number: CDS982898G, Case UDI/GTIN: 40889942217411, Unit UDI/GTIN: 10889942217410, Lot Number: 22IBO658,22IBN353,22IBF023; q. MINOR CDS-1, Item Number: CDS982899F, Case UDI/GTIN: 40889942216933, Unit UDI/GTIN: 10889942216932, Lot Number: 22KBD131,22IBU676,22IBD867; r. VASCULAR CDS-4, Item Number: CDS983003F, Case UDI/GTIN: 40889942217459, Unit UDI/GTIN: 10889942217458, Lot Number: 22JBG357,22IBQ259; s. SEPTOPLASTY CDS, Item Number: CDS983100C, Case UDI/GTIN: 40889942926764, Unit UDI/GTIN: 10889942926763, Lot Number: 22JBB204; t. DENTAL CDS, Item Number: CDS983103C, Case UDI/GTIN: 40889942926672, Unit UDI/GTIN: 10889942926671, Lot Number: 22JBR350,22JBO090,22JBJ684; u. MINOR GENERAL CDS, Item Number: CDS983109F, Case UDI/GTIN: 40193489202343, Unit UDI/GTIN: 10193489202342, Lot Number: 22KBF514,22JBD721; v. CUH UROLOGY LITHOTOMY CDS, Item Number: CDS983180L, Case UDI/GTIN: 40195327179626, Unit UDI/GTIN: 10195327179625, Lot Number: 22JBM355; w. CUH UROLOGY OPEN CDS, Item Number: CDS983191G, Case UDI/GTIN: 40888277781673, Unit UDI/GTIN: 10888277781672, Lot Number: 22JBM356,22IBC756; x. CUH LIVER TRANSPLANT CDS, Item Number: CDS983654K, Case UDI/GTIN: 40195327164561, Unit UDI/GTIN: 10195327164560, Lot Number: 22JBO589; y. THORACOTOMY CDS, Item Number: CDS983692K, Case UDI/GTIN: 40193489953573, Unit UDI/GTIN: 10193489953572, Lot Number: 22JBR359; z. XI THORACIC ROBOTIC CDS, Item Number: CDS984338K, Case UDI/GTIN: 40195327221240, Unit UDI/GTIN: 10195327221249, Lot Number: 22KBG387; aa. GENERAL CDS, Item Number: CDS984628L, Case UDI/GTIN: 40195327070763, Unit UDI/GTIN: 10195327070762, Lot Number: 22JBH835,22IBU580; bb. THORACIC CDS, Item Number: CDS984637F, Case UDI/GTIN: 40193489861441, Unit UDI/GTIN: 10193489861440, Lot Number: 22IBF812,22IBD913,22IBA427; cc. MINOR PROCEDURE, Item Number: CDS984897J, Case UDI/GTIN: 40193489983846, Unit UDI/GTIN: 10193489983845, Lot Number: 22JBC519; dd. EXTREMITY CDS, Item Number: CDS985203B, Case UDI/GTIN: 40889942941613, Unit UDI/GTIN: 10889942941612, Lot Number: 22JBE301,22JBA666; ee. DOUBLE BASIN CDS, Item Number: CDS985205B, Case UDI/GTIN: 40889942941620, Unit UDI/GTIN: 10889942941629, Lot Number: 22KBH397; ff. PEDIATRIC, Item Number: CDS985465D, Case UDI/GTIN: 40195327090785, Unit UDI/GTIN: 10195327090784, Lot Number: 22IDA937; gg. P.V.STARTER TRAY, Item Number: CV6222T, Case UDI/GTIN: 40193489314626, Unit UDI/GTIN: 10193489314625, Lot Number: 22JLA509,22ILA422; hh. CV PACK, Item Number: CVT079R, Case UDI/GTIN: 40193489215619, Unit UDI/GTIN: 10193489215618, Lot Number: 22JBJ591; ii. MINOR GENERAL-LF, Item Number: DYNJ00199D, Case UDI/GTIN: 40884389429991, Unit UDI/GTIN: 10884389429990, Lot Number: 22IBN962; jj. VASCULAR PACK-LF, Item Number: DYNJ00203D, Case UDI/GTIN: 40888277206459, Unit UDI/GTIN: 10888277206458, Lot Number: 22IBT212; kk. UROLOGY PACK, Item Number: DYNJ01038J, Case UDI/GTIN: 40889942864820, Unit UDI/GTIN: 10889942864829, Lot Number: 22JDA606; ll. MINOR LINEN PACK-LF, Item Number: DYNJ0112530T, Case UDI/GTIN: 40195327115785, Unit UDI/GTIN: 10195327115784, Lot Number: 22JMI192; mm. ABDOMINAL PACK-LF, Item Number: DYNJ0149594F, Case UDI/GTIN: 40193489730228, Unit UDI/GTIN: 10193489730227, Lot Number: 22IMI490,22HME197; nn. MINOR SURGICAL SETUP PACK-LF, Item Number: DYNJ0151516B, Case UDI/GTIN: 40889942216346, Unit UDI/GTIN: 10889942216345, Lot Number: 22HDC003; oo. MINOR GENERAL PACK-LF, Item Number: DYNJ0159495C, Case UDI/GTIN: 40889942214427, Unit UDI/GTIN: 10889942214426, Lot Number: 22IDB673; pp. MAJOR ABDOMINAL PACK-LF, Item Number: DYNJ0159548D, Case UDI/GTIN: 40193489207447, Unit UDI/GTIN: 10193489207446, Lot Number: 22JDA012,22HDB747; qq. MINOR VASCULAR PACK-LF, Item Number: DYNJ0160151A, Case UDI/GTIN: 40889942051725, Unit UDI/GTIN: 10889942051724, Lot Number: 22JDC189,22IDB468; rr. MAJOR BASIN PACK-LF, Item Number: DYNJ0160289A, Case UDI/GTIN: 40889942051749, Unit UDI/GTIN: 10889942051748, Lot Number: 22JDC198; ss. DAVINCI PACK-LF, Item Number: DYNJ0160306D, Case UDI/GTIN: 40193489521352, Unit UDI/GTIN: 10193489521351, Lot Number: 22JDC152,22IDA021; tt. MINOR ENT HARPER PACK-LF, Item Number: DYNJ0160700D, Case UDI/GTIN: 40193489205597, Unit UDI/GTIN: 10193489205596, Lot Number: 22IDC074,22IDA779,22IDA853,22IDA192,22HDB958; uu. CHOM START UP PACK-LF, Item Number: DYNJ0161358B, Case UDI/GTIN: 40889942213260, Unit UDI/GTIN: 10889942213269, Lot Number: 22JDC165; vv. MINOR HARPER PACK-LF, Item Number: DYNJ0161694D, Case UDI/GTIN: 40889942219620, Unit UDI/GTIN: 10889942219629, Lot Number: 22IDB272,22IDA785; ww. MAJOR ENT HARPER PACK-LF, Item Number: DYNJ0161710F, Case UDI/GTIN: 40193489205573, Unit UDI/GTIN: 10193489205572, Lot Number: 22JDC154,22IDA194; xx. THROMBECTOMY HARPER PACK-LF, Item Number: DYNJ0161832D, Case UDI/GTIN: 40193489205559, Unit UDI/GTIN: 10193489205558, Lot Number: 22IDB848,22IDA001; yy. PENILE PROSTHESIS HARPER PK-LF, Item Number: DYNJ0161854C, Case UDI/GTIN: 40193489205429, Unit UDI/GTIN: 10193489205428, Lot Number: 22JDA162; zz. RECONSTRUCTIVE PACK-LF, Item Number: DYNJ0185115N, Case UDI/GTIN: 40193489376389, Unit UDI/GTIN: 10193489376388, Lot Number: 22HME609; aaa. CUSTOM COLIC PACK, Item Number: DYNJ0190097D, Case UDI/GTIN: 40193489357500, Unit UDI/GTIN: 10193489357509, Lot Number: 22IMB627; bbb. MAJOR PACK, Item Number: DYNJ01922K, Case UDI/GTIN: 40193489775564, Unit UDI/GTIN: 10193489775563, Lot Number: 22HBF615; ccc. ROBOTIC PACK, Item Number: DYNJ02314G, Case UDI/GTIN: 40193489669696, Unit UDI/GTIN: 10193489669695, Lot Number: 22IMD665; ddd. MINOR PACK, Item Number: DYNJ02480D, Case UDI/GTIN: 40193489775625, Unit UDI/GTIN: 10193489775624, Lot Number: 22JBO134; eee. MINOR PACK-LF, Item Number: DYNJ0259893S, Case UDI/GTIN: 40193489506960, Unit UDI/GTIN: 10193489506969, Lot Number: 22IMF443; fff. CT THORACIC PACK, Item Number: DYNJ0271168Q, Case UDI/GTIN: 40195327089277, Unit UDI/GTIN: 10195327089276, Lot Number: 22JBK798,22IBF123; ggg. KIDNEY TRANSPLANT PACK-LF, Item Number: DYNJ0282000U, Case UDI/GTIN: 40195327088485, Unit UDI/GTIN: 10195327088484, Lot Number: 22JDB414,22JDA237; hhh. DAVINCI ROBOTIC PACK, Item Number: DYNJ02857C, Case UDI/GTIN: 40888277743657, Unit UDI/GTIN: 10888277743656, Lot Number: 22IMC528; iii. MAJOR UNIVERSAL PACK-LF, Item Number: DYNJ0341046F, Case UDI/GTIN: 40193489735094, Unit UDI/GTIN: 10193489735093, Lot Number: 22IME563,22HMC086; jjj. BASIC SETUP PACK-LF, Item Number: DYNJ0371494M, Case UDI/GTIN: 40889942492955, Unit UDI/GTIN: 10889942492954, Lot Number: 22IMH376; kkk. BASIC ABDOMINAL PACK-LF, Item Number: DYNJ0374119M, Case UDI/GTIN: 40889942902133, Unit UDI/GTIN: 10889942902132, Lot Number: 22JBY441,22JBO082,22HBT994; lll. PENILE IMPLANT PACK-LF, Item Number: DYNJ0374945M, Case UDI/GTIN: 40193489466721, Unit UDI/GTIN: 10193489466720, Lot Number: 22HBY419; mmm. VALVE UNIV OF CINN PACK-LF, Item Number: DYNJ0375673L, Case UDI/GTIN: 40193489544122, Unit UDI/GTIN: 10193489544121, Lot Number: 22IBL136; nnn. CABG UNIVERSITY HOSP PACK-LF, Item Number: DYNJ0375705L, Case UDI/GTIN: 40193489544139, Unit UDI/GTIN: 10193489544138, Lot Number: 22JBO601; ooo. AAA - UNIV, Item Number: DYNJ0375731N, Case UDI/GTIN: 40193489423229, Unit UDI/GTIN: 10193489423228, Lot Number: 22JBI941; ppp. LIVER TRANSPLNT UNIV CI PK-LF, Item Number: DYNJ0376001O, Case UDI/GTIN: 40193489544207, Unit UDI/GTIN: 10193489544206, Lot Number: 22IBG362; qqq. AV FISTULA PACK-LF, Item Number: DYNJ0376614I, Case UDI/GTIN: 40889942419662, Unit UDI/GTIN: 10889942419661, Lot Number: 22JMH867; rrr. MAJOR PACK-LF, Item Number: DYNJ0378191M, Case UDI/GTIN: 40889942469339, Unit UDI/GTIN: 10889942469338, Lot Number: 22HME980; sss. MINOR SNGL BASIN PACK-LF, Item Number: DYNJ0379441D, Case UDI/GTIN: 40193489348058, Unit UDI/GTIN: 10193489348057, Lot Number: 22IMB634; ttt. MAJOR BASIN PACK-LF, Item Number: DYNJ0381555J, Case UDI/GTIN: 40193489475365, Unit UDI/GTIN: 10193489475364, Lot Number: 22JBO287; uuu. MAJOR PACK L-F, Item Number: DYNJ0382730L, Case UDI/GTIN: 40193489899291, Unit UDI/GTIN: 10193489899290, Lot Number: 22JMG763,22IMG639; vvv. PEDIATRIC PACK, Item Number: DYNJ0382751P, Case UDI/GTIN: 40193489899307, Unit UDI/GTIN: 10193489899306, Lot Number: 22JME325; www. BASIC PACK-LF, Item Number: DYNJ0382788P, Case UDI/GTIN: 40193489899314, Unit UDI/GTIN: 10193489899313, Lot Number: 22JMA518,22IMB261; xxx. BASIC PACK-LF, Item Number: DYNJ0387695D, Case UDI/GTIN: 40195327270149, Unit UDI/GTIN: 10195327270148, Lot Number: 22JMI200; yyy. MAJOR PACK-LF, Item Number: DYNJ0400297K, Case UDI/GTIN: 40889942402374, Unit UDI/GTIN: 10889942402373, Lot Number: 22JMG608,22IMH378; zzz. MAJOR PACK, Item Number: DYNJ04379K, Case UDI/GTIN: 40193489552011, Unit UDI/GTIN: 10193489552010, Lot Number: 22IMI201,22HME526; aaaa. MINOR PACK, Item Number: DYNJ04380J, Case UDI/GTIN: 40193489552028, Unit UDI/GTIN: 10193489552027, Lot Number: 22JMC853,22JMC970; bbbb. UPPER EXTREMITY PACK-LF, Item Number: DYNJ04438L, Case UDI/GTIN: 40888277753380, Unit UDI/GTIN: 10888277753389, Lot Number: 22JMB708; cccc. MAJOR PACK-LF, Item Number: DYNJ04443L, Case UDI/GTIN: 40193489554183, Unit UDI/GTIN: 10193489554182, Lot Number: 22JMC971,22JMB709,22HMC674; dddd. DR PALEY ILIZAROV PACK-LF, Item Number: DYNJ0445416N, Case UDI/GTIN: 40193489899260, Unit UDI/GTIN: 10193489899269, Lot Number: 22HBT955,22HBT622; eeee. MAJOR PACK, Item Number: DYNJ04459L, Case UDI/GTIN: 40195327032389, Unit UDI/GTIN: 10195327032388, Lot Number: 22JMC972,22IMB642; ffff. BASIC PACK-LF, Item Number: DYNJ04514M, Case UDI/GTIN: 40888277744067, Unit UDI/GTIN: 10888277744066, Lot Number: 22JMC973; gggg. MAJOR PACK, Item Number: DYNJ04524F, Case UDI/GTIN: 40888277744234, Unit UDI/GTIN: 10888277744233, Lot Number: 22JMH182; hhhh. MAJOR LITHOTOMY PACK, Item Number: DYNJ04541M, Case UDI/GTIN: 40193489553544, Unit UDI/GTIN: 10193489553543, Lot Number: 22JMA298; iiii. MAJOR LITHOTOMY PACK-LF, Item Number: DYNJ04602I, Case UDI/GTIN: 40193489552714, Unit UDI/GTIN: 10193489552713, Lot Number: 22HMF017; jjjj. MAJOR PACK, Item...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 15, 2023
Recall initiation date: Nov 17, 2022
Center classification date: Feb 6, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records