Recall archive / FDA device enforcement

Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS... — FDA record Z-1072-2023

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. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l. MINOR ENT SINUS PACK-LF m. MAJOR EAR PACK-LF n. THORACOTOMY HARPER PACK-LF o. FESS NSR PACK-LF p. ENT BASIC PACK-LF q. HEAD & NECK-LF r. ENT PACK-LF s. SINOSCOPY-LF t. MAJOR HEAD/NECK PACK-LF u. NECK PACK v. HEAD & NECK PACK w. HEAD & NECK TRAY x. ENT LAW PACK-LF y. ENT PACK z. NECK PACK aa. NASAL PACK bb. ENT PACK cc. FREE FLAP PACK-LF dd. TYMPANO MASTOID ee. MINOR HEAD & NECK #40-RF ff. EAR PACK gg. E.N.T. TRAY hh. EAR PACK-LF ii. BASIC ENT PACK-LF jj. PLASTIC HEAD & NECK PACK kk. EAR TRAY #10-RF ll. HEAD & NECK ENT PACK-RF-LF mm. ENT PACK nn. ENT PACK-LF oo. NASAL/SEPTO PACK pp. OSC FACE LIFT PK qq. RRMC NASAL PACK rr. ENT PACK ss. HENRYS ENT PACK tt. ENT uu. FACE AND NASAL PACK vv. NASAL PACK ww. ENT PACK xx. SINUS ENDOSCOPY-LF yy. OSC NASAL-NOSE PACK-LF zz. ENT PACK aaa. FES PACK - LF bbb. HEAD AND NECK PACK ccc. SCRIPPS SW ENT PACK ddd. SCRIPPS SW EAR PACK-LF eee. HL ENT PACK fff. CAROTID ENDARTECTOMY PK ggg. EAR PACK hhh. ENT FREE FLAP iii. HEAD AND NECK PACK jjj. TRACH PACK kkk. HL EAR PACK lll. NASAL SINUS ENDO PK mmm. ENT PACK nnn. HEAD AND NECK PACK ooo. ENT PACK ppp. HEAD AND NECK PACK qqq. ASC HEAD & NECK PACK rrr. ENT PACK sss. DEACONESS HEAD AND NECK PACK ttt. ENT PACK uuu. BEC MOHS PACK vvv. PK,ENT-EAR www. SVMMC HEAD AND NECK PACK xxx. PK, ENT yyy. HEAD AND NECK PACK zzz. FESS PACK aaaa. PK,ENT-SINUS bbbb. NASAL/HEAD & NECK PACK cccc. ENT PACK dddd. ENT PACK eeee. MAJOR ENT PACK ffff. ENT NECK MMC PACK gggg. HEAD AND NECK PACK hhhh. HEAD AND NECK PACK iiii. HEAD AND NECK PACK jjjj. ORAL PACK kkkk. HMT THORACOSCOPY PACK llll. GU PACK mmmm. HEAD NECKPACK (HNSJC)227-LF nnnn. HEAD AND NECK PLUS I PACK oooo. NASAL PACK pppp. HEAD & NECK PACK-RFD-LF qqqq. ENT PACK rrrr. ENT/H&N PACK ssss. C-SECTION PACK tttt. ENT PACK uuuu. ENT PACK vvvv. ENT PACK wwww. NASAL ENT PACK xxxx. SINUS PACK yyyy. HEAD/NECK PACK zzzz. ENT PACK aaaaa. NASAL PACK bbbbb. FESS PACK ccccc. NASAL SEPTOPLASTY PACK ddddd. ENT PACK eeeee. HEAD&NECK fffff. EAR PACK-LF ggggg. HEAD AND NECK PACK-LF hhhhh. EAR BASIC PACK iiiii. HEAD AND NECK PACK jjjjj. ENT/SEPTO PACK kkkkk. ENT PACK lllll. HEAD & NECK PACK mmmmm. HEAD AND NECK PACK nnnnn. ENT PACK ooooo. ENT PACK-LF ppppp. ENT PACK-LF qqqqq. HL DR PETERS ENT PACK rrrrr. RHINO/SEPTO/FESS PACK sssss. HEAD & NECK ttttt. THYROID/PARATHYROID PACK uuuuu. HEAD AND NECK MINOR PACK vvvvv. PK,ENT wwwww. ENT PACK xxxxx. ENT PACK yyyyy. ENT PACK zzzzz. ENT NECK PACK aaaaaa. ENT PACK bbbbbb. NECK PACK cccccc. EAR TRAY dddddd. HEAD & NECK PACK eeeeee. HEAD & NECK PACK ffffff. MHPB HEAD AND NECK PACK gggggg. NASAL PACK hhhhhh. ENT PACK iiiiii. JHOC EAR TRAY jjjjjj. JHOC HEAD TRAY kkkkkk. ENT I llllll. ENT SHARED mmmmmm. ENT PACK nnnnnn. EENT SPLIT PACK-NO G...
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: 9,079 cases (27,563 units)
Agency-reported status: Ongoing
Source record identifier: Z-1072-2023

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. EAR CDS-LF, Item Number: CDS982612B, Case UDI/GTIN: 40888277899729, Unit UDI/GTIN: 10888277899728, Lot Number: 22JBH351,22JBA043; b. SINUS CDS-1, Item Number: CDS982901F, Case UDI/GTIN: 40889942216971, Unit UDI/GTIN: 10889942216970, Lot Number: 22KBD129; c. ZALE FESS CDS, Item Number: CDS983178F, Case UDI/GTIN: 40195327164639, Unit UDI/GTIN: 10195327164638, Lot Number: 22JBC334,22IBC429; d. ZALE OTOLOGY CDS, Item Number: CDS983181F, Case UDI/GTIN: 40195327164646, Unit UDI/GTIN: 10195327164645, Lot Number: 22IBQ523,22IBJ058; e. ZALE HEAD & NECK CDS, Item Number: CDS983184I, Case UDI/GTIN: 40195327178353, Unit UDI/GTIN: 10195327178352, Lot Number: 22IBO795,22IBJ687; f. CUH PARA/THYROIDECTOMY CDS, Item Number: CDS983209J, Case UDI/GTIN: 40195327179794, Unit UDI/GTIN: 10195327179793, Lot Number: 22JBC280; g. CAM ENDOSCOPIC SINUS/SEPTO CDS, Item Number: CDS983499D, Case UDI/GTIN: 40193489749756, Unit UDI/GTIN: 10193489749755, Lot Number: 22IBU380,22HBW179; h. HEAD AND NECK CDS, Item Number: CDS983910K, Case UDI/GTIN: 40195327256594, Unit UDI/GTIN: 10195327256593, Lot Number: 22JBT244; i. HEAD AND NECK CDS-LF, Item Number: CDS984857J, Case UDI/GTIN: 40195327090808, Unit UDI/GTIN: 10195327090807, Lot Number: 22JDB038,22IDA739; j. NASAL, Item Number: CDS984899G, Case UDI/GTIN: 40193489983822, Unit UDI/GTIN: 10193489983821, Lot Number: 22IBC505; k. ENT SET UP CDS, Item Number: CDS985421G, Case UDI/GTIN: 40193489319300, Unit UDI/GTIN: 10193489319309, Lot Number: 22KBG050,22HBX042; l. MINOR ENT SINUS PACK-LF, Item Number: DYNJ0101278F, Case UDI/GTIN: 40193489352352, Unit UDI/GTIN: 10193489352351, Lot Number: 22HDC403; m. MAJOR EAR PACK-LF, Item Number: DYNJ0101314C, Case UDI/GTIN: 40193489451093, Unit UDI/GTIN: 10193489451092, Lot Number: 22JDA679,22HDC440; n. THORACOTOMY HARPER PACK-LF, Item Number: DYNJ0161795C, Case UDI/GTIN: 40889942216629, Unit UDI/GTIN: 10889942216628, Lot Number: 22IDB179; o. FESS NSR PACK-LF, Item Number: DYNJ0381496I, Case UDI/GTIN: 40193489475310, Unit UDI/GTIN: 10193489475319, Lot Number: 22JBH235; p. ENT BASIC PACK-LF, Item Number: DYNJ0387711D, Case UDI/GTIN: 40195327270156, Unit UDI/GTIN: 10195327270155, Lot Number: 22JMI201; q. HEAD & NECK-LF, Item Number: DYNJ04437J, Case UDI/GTIN: 40193489274494, Unit UDI/GTIN: 10193489274493, Lot Number: 22JMI207; r. ENT PACK-LF, Item Number: DYNJ04591F, Case UDI/GTIN: 40193489551434, Unit UDI/GTIN: 10193489551433, Lot Number: 22JMH877; s. SINOSCOPY-LF, Item Number: DYNJ06621D, Case UDI/GTIN: 40888277854698, Unit UDI/GTIN: 10888277854697, Lot Number: 22JBM104,22HBX999; t. MAJOR HEAD/NECK PACK-LF, Item Number: DYNJ0826705N, Case UDI/GTIN: 40193489265683, Unit UDI/GTIN: 10193489265682, Lot Number: 22JMD563,22JMD586; u. NECK PACK, Item Number: DYNJ13175, Case UDI/GTIN: 40195327215782, Unit UDI/GTIN: 10195327215781, Lot Number: 22JBG041; v. HEAD & NECK PACK, Item Number: DYNJ14069B, Case UDI/GTIN: 40884389223025, Unit UDI/GTIN: 10884389223024, Lot Number: 22JBI051,22IBQ751,22IBB059; w. HEAD & NECK TRAY, Item Number: DYNJ15653J, Case UDI/GTIN: 40193489767996, Unit UDI/GTIN: 10193489767995, Lot Number: 22JBE697; x. ENT LAW PACK-LF, Item Number: DYNJ16428L, Case UDI/GTIN: 40195327084821, Unit UDI/GTIN: 10195327084820, Lot Number: 22JMD569,22HMB943; y. ENT PACK, Item Number: DYNJ17203I, Case UDI/GTIN: 40193489668170, Unit UDI/GTIN: 10193489668179, Lot Number: 22IDB986; z. NECK PACK, Item Number: DYNJ17213D, Case UDI/GTIN: 40193489668477, Unit UDI/GTIN: 10193489668476, Lot Number: 22JDA408; aa. NASAL PACK, Item Number: DYNJ17493G, Case UDI/GTIN: 40195327224425, Unit UDI/GTIN: 10195327224424, Lot Number: 22HBR581; bb. ENT PACK, Item Number: DYNJ19846J, Case UDI/GTIN: 40888277850997, Unit UDI/GTIN: 10888277850996, Lot Number: 22IBV046; cc. FREE FLAP PACK-LF, Item Number: DYNJ20495J, Case UDI/GTIN: 40195327024407, Unit UDI/GTIN: 10195327024406, Lot Number: 22JDA143; dd. TYMPANO MASTOID, Item Number: DYNJ21567A, Case UDI/GTIN: 40080196015345, Unit UDI/GTIN: 10080196015344, Lot Number: 22JBD171,22IBE475,22HBK016; ee. MINOR HEAD & NECK #40-RF, Item Number: DYNJ21948S, Case UDI/GTIN: 40195327104727, Unit UDI/GTIN: 10195327104726, Lot Number: 22JBB180,22JBC021; ff. EAR PACK, Item Number: DYNJ22136B, Case UDI/GTIN: 40193489228220, Unit UDI/GTIN: 10193489228229, Lot Number: 22KMA168; gg. E.N.T. TRAY, Item Number: DYNJ22357K, Case UDI/GTIN: 40193489926737, Unit UDI/GTIN: 10193489926736, Lot Number: 22KBB868,22JBE605,22IBD335,22HBJ735; hh. EAR PACK-LF, Item Number: DYNJ24092M, Case UDI/GTIN: 40195327024421, Unit UDI/GTIN: 10195327024420, Lot Number: 22IDA807; ii. BASIC ENT PACK-LF, Item Number: DYNJ24912K, Case UDI/GTIN: 40193489992862, Unit UDI/GTIN: 10193489992861, Lot Number: 22IBL139,22HBV866,22HBU453,22HBT633,22HBP897; jj. PLASTIC HEAD & NECK PACK, Item Number: DYNJ24941M, Case UDI/GTIN: 40889942176329, Unit UDI/GTIN: 10889942176328, Lot Number: 22IDC167; kk. EAR TRAY #10-RF, Item Number: DYNJ27428R, Case UDI/GTIN: 40195327114900, Unit UDI/GTIN: 10195327114909, Lot Number: 22JBI743; ll. HEAD & NECK ENT PACK-RF-LF, Item Number: DYNJ30604P, Case UDI/GTIN: 40193489962834, Unit UDI/GTIN: 10193489962833, Lot Number: 22IBU329,22IBU962; mm. ENT PACK, Item Number: DYNJ30988C, Case UDI/GTIN: 40889942715719, Unit UDI/GTIN: 10889942715718, Lot Number: 22IBI164; nn. ENT PACK-LF, Item Number: DYNJ31584I, Case UDI/GTIN: 40193489504416, Unit UDI/GTIN: 10193489504415, Lot Number: 22JME741,22IMG343; oo. NASAL/SEPTO PACK, Item Number: DYNJ32099, Case UDI/GTIN: 40884389092911, Unit UDI/GTIN: 10884389092910, Lot Number: 22KBA569; pp. OSC FACE LIFT PK, Item Number: DYNJ32855B, Case UDI/GTIN: 40889942465218, Unit UDI/GTIN: 10889942465217, Lot Number: 22IBH454; qq. RRMC NASAL PACK, Item Number: DYNJ33396G, Case UDI/GTIN: 40193489914574, Unit UDI/GTIN: 10193489914573, Lot Number: 22JMD009; rr. ENT PACK, Item Number: DYNJ33698D, Case UDI/GTIN: 40889942689355, Unit UDI/GTIN: 10889942689354, Lot Number: 22JBY709,22IBF415; ss. HENRYS ENT PACK, Item Number: DYNJ34093F, Case UDI/GTIN: 40193489274685, Unit UDI/GTIN: 10193489274684, Lot Number: 22JMC221; tt. ENT, Item Number: DYNJ34426I, Case UDI/GTIN: 40193489224703, Unit UDI/GTIN: 10193489224702, Lot Number: 22JMA985; uu. FACE AND NASAL PACK, Item Number: DYNJ35554B, Case UDI/GTIN: 40195327097869, Unit UDI/GTIN: 10195327097868, Lot Number: 22IBQ641; vv. NASAL PACK, Item Number: DYNJ35803A, Case UDI/GTIN: 40889942557210, Unit UDI/GTIN: 10889942557219, Lot Number: 22JBE657; ww. ENT PACK, Item Number: DYNJ36516, Case UDI/GTIN: 40884389544113, Unit UDI/GTIN: 10884389544112, Lot Number: 22HBS907; xx. SINUS ENDOSCOPY-LF, Item Number: DYNJ36720D, Case UDI/GTIN: 40195327148684, Unit UDI/GTIN: 10195327148683, Lot Number: 22JBA686; yy. OSC NASAL-NOSE PACK-LF, Item Number: DYNJ37383C, Case UDI/GTIN: 40889942465256, Unit UDI/GTIN: 10889942465255, Lot Number: 22JBA361,22HBN245,22HBN978,22HBL526; zz. ENT PACK, Item Number: DYNJ38321D, Case UDI/GTIN: 40195327103591, Unit UDI/GTIN: 10195327103590, Lot Number: 22JBQ451; aaa. FES PACK - LF, Item Number: DYNJ38730C, Case UDI/GTIN: 40195327100316, Unit UDI/GTIN: 10195327100315, Lot Number: 22JMC574; bbb. HEAD AND NECK PACK, Item Number: DYNJ38880D, Case UDI/GTIN: 40193489997331, Unit UDI/GTIN: 10193489997330, Lot Number: 22JMA087; ccc. SCRIPPS SW ENT PACK, Item Number: DYNJ39829D, Case UDI/GTIN: 40195327176571, Unit UDI/GTIN: 10195327176570, Lot Number: 22IMI295,22HME428; ddd. SCRIPPS SW EAR PACK-LF, Item Number: DYNJ39858B, Case UDI/GTIN: 40195327179466, Unit UDI/GTIN: 10195327179465, Lot Number: 22JMA176; eee. HL ENT PACK, Item Number: DYNJ40360D, Case UDI/GTIN: 40889942697176, Unit UDI/GTIN: 10889942697175, Lot Number: 22JBL587,22IBS429,22IBU440; fff. CAROTID ENDARTECTOMY PK, Item Number: DYNJ40386B, Case UDI/GTIN: 40889942215769, Unit UDI/GTIN: 10889942215768, Lot Number: 22IBP925; ggg. EAR PACK, Item Number: DYNJ40401B, Case UDI/GTIN: 40193489231527, Unit UDI/GTIN: 10193489231526, Lot Number: 22JBI621,22HBS976,22HBK587; hhh. ENT FREE FLAP, Item Number: DYNJ40403D, Case UDI/GTIN: 40193489373531, Unit UDI/GTIN: 10193489373530, Lot Number: 22IBU477,22HBT008; iii. HEAD AND NECK PACK, Item Number: DYNJ40411A, Case UDI/GTIN: 40889942216094, Unit UDI/GTIN: 10889942216093, Lot Number: 22JBI783,22IBG980,22HBI781; jjj. TRACH PACK, Item Number: DYNJ40431A, Case UDI/GTIN: 40889942215691, Unit UDI/GTIN: 10889942215690, Lot Number: 22JBP822,22HBS909; kkk. HL EAR PACK, Item Number: DYNJ40560A, Case UDI/GTIN: 40889942529897, Unit UDI/GTIN: 10889942529896, Lot Number: 22HBZ367; lll. NASAL SINUS ENDO PK, Item Number: DYNJ41024C, Case UDI/GTIN: 40889942233466, Unit UDI/GTIN: 10889942233465, Lot Number: 22IBS024; mmm. ENT PACK, Item Number: DYNJ41060A, Case UDI/GTIN: 40195327025428, Unit UDI/GTIN: 10195327025427, Lot Number: 22IBQ559,22IBL826,22IBL050; nnn. HEAD AND NECK PACK, Item Number: DYNJ41270B, Case UDI/GTIN: 40193489789080, Unit UDI/GTIN: 10193489789089, Lot Number: 22JMB156,22JMB478,22JMA301; ooo. ENT PACK, Item Number: DYNJ41327C, Case UDI/GTIN: 40193489923156, Unit UDI/GTIN: 10193489923155, Lot Number: 22JBW436,22HBI717; ppp. HEAD AND NECK PACK, Item Number: DYNJ42004B, Case UDI/GTIN: 40888277918239, Unit UDI/GTIN: 10888277918238, Lot Number: 22JMC585; qqq. ASC HEAD & NECK PACK, Item Number: DYNJ42019B, Case UDI/GTIN: 40888277938329, Unit UDI/GTIN: 10888277938328, Lot Number: 22IBM163,22HBL313; rrr. ENT PACK, Item Number: DYNJ42228B, Case UDI/GTIN: 40193489878975, Unit UDI/GTIN: 10193489878974, Lot Number: 22IMB508; sss. DEACONESS HEAD AND NECK PACK, Item Number: DYNJ42242, Case UDI/GTIN: 40884389921280, Unit UDI/GTIN: 10884389921289, Lot Number: 22HBY134,22HBZ333; ttt. ENT PACK, Item Number: DYNJ42564B, Case UDI/GTIN: 40193489685047, Unit UDI/GTIN: 10193489685046, Lot Number: 22IBC952; uuu. BEC MOHS PACK, Item Number: DYNJ43111G, Case UDI/GTIN: 40195327007615, Unit UDI/GTIN: 10195327007614, Lot Number: 22JBK014; vvv. PK,ENT-EAR, Item Number: DYNJ43700A, Case UDI/GTIN: 40193489332194, Unit UDI/GTIN: 10193489332193, Lot Number: 22HBS025,22HBP684; www. SVMMC HEAD AND NECK PACK, Item Number: DYNJ43776G, Case UDI/GTIN: 40193489989718, Unit UDI/GTIN: 10193489989717, Lot Number: 22JBG530,22JBD640; xxx. PK, ENT, Item Number: DYNJ43875B, Case UDI/GTIN: 40193489427876, Unit UDI/GTIN: 10193489427875, Lot Number: 22JBM105,22IBC196; yyy. HEAD AND NECK PACK, Item Number: DYNJ44019B, Case UDI/GTIN: 40193489795081, Unit UDI/GTIN: 10193489795080, Lot Number: 22HBY533,22HBM204; zzz. FESS PACK, Item Number: DYNJ44080A, Case UDI/GTIN: 40888277279774, Unit UDI/GTIN: 10888277279773, Lot Number: 22IBV695; aaaa. PK,ENT-SINUS, Item Number: DYNJ45036D, Case UDI/GTIN: 40193489259903, Unit UDI/GTIN: 10193489259902, Lot Number: 22JBF806,22HBG764; bbbb. NASAL/HEAD & NECK PACK, Item Number: DYNJ45078C, Case UDI/GTIN: 40195327045204, Unit UDI/GTIN: 10195327045203, Lot Number: 22JBL812,22JBL819; cccc. ENT PACK, Item Number: DYNJ45175B, Case UDI/GTIN: 40889942485216, Unit UDI/GTIN: 10889942485215, Lot Number: 22HLA901; dddd. ENT PACK, Item Number: DYNJ45260B, Case UDI/GTIN: 40193489852449, Unit UDI/GTIN: 10193489852448, Lot Number: 22JBU804; eeee. MAJOR ENT PACK, Item Number: DYNJ45576B, Case UDI/GTIN: 40195327059201, Unit UDI/GTIN: 10195327059200, Lot Number: 22JBD150,22IBS180; ffff. ENT NECK MMC PACK, Item Number: DYNJ46091G, Case UDI/GTIN: 40193489496452, Unit UDI/GTIN: 10193489496451, Lot Number: 22HDB941; gggg. HEAD AND NECK PACK, Item Number: DYNJ46216I, Case UDI/GTIN: 40195327160341, Unit UDI/GTIN: 10195327160340, Lot Number: 22JBE614,22JBE616,22IBI293; hhhh. HEAD AND NECK PACK, Item Number: DYNJ46486B, Case UDI/GTIN: 40193489472159, Unit UDI/GTIN: 10193489472158, Lot Number: 22IBH413; iiii. HEAD AND NECK PACK, Item Number: DYNJ46509G, Case UDI/GTIN: 40195327001002, Unit UDI/GTIN: 10195327001001, Lot Number: 22HMD805; jjjj. ORAL PACK, Item Number: DYNJ46541J, Case UDI/GTIN: 40195327067909, Unit UDI/GTIN: 10195327067908, Lot Number: 22HME315; kkkk. HMT THORACOSCOPY PACK, Item Number: DYNJ47230K, Case U...

Label field

Details supplied by the agency

Lot, code or applicability

a. EAR CDS-LF, Item Number: CDS982612B, Case UDI/GTIN: 40888277899729, Unit UDI/GTIN: 10888277899728, Lot Number: 22JBH351,22JBA043; b. SINUS CDS-1, Item Number: CDS982901F, Case UDI/GTIN: 40889942216971, Unit UDI/GTIN: 10889942216970, Lot Number: 22KBD129; c. ZALE FESS CDS, Item Number: CDS983178F, Case UDI/GTIN: 40195327164639, Unit UDI/GTIN: 10195327164638, Lot Number: 22JBC334,22IBC429; d. ZALE OTOLOGY CDS, Item Number: CDS983181F, Case UDI/GTIN: 40195327164646, Unit UDI/GTIN: 10195327164645, Lot Number: 22IBQ523,22IBJ058; e. ZALE HEAD & NECK CDS, Item Number: CDS983184I, Case UDI/GTIN: 40195327178353, Unit UDI/GTIN: 10195327178352, Lot Number: 22IBO795,22IBJ687; f. CUH PARA/THYROIDECTOMY CDS, Item Number: CDS983209J, Case UDI/GTIN: 40195327179794, Unit UDI/GTIN: 10195327179793, Lot Number: 22JBC280; g. CAM ENDOSCOPIC SINUS/SEPTO CDS, Item Number: CDS983499D, Case UDI/GTIN: 40193489749756, Unit UDI/GTIN: 10193489749755, Lot Number: 22IBU380,22HBW179; h. HEAD AND NECK CDS, Item Number: CDS983910K, Case UDI/GTIN: 40195327256594, Unit UDI/GTIN: 10195327256593, Lot Number: 22JBT244; i. HEAD AND NECK CDS-LF, Item Number: CDS984857J, Case UDI/GTIN: 40195327090808, Unit UDI/GTIN: 10195327090807, Lot Number: 22JDB038,22IDA739; j. NASAL, Item Number: CDS984899G, Case UDI/GTIN: 40193489983822, Unit UDI/GTIN: 10193489983821, Lot Number: 22IBC505; k. ENT SET UP CDS, Item Number: CDS985421G, Case UDI/GTIN: 40193489319300, Unit UDI/GTIN: 10193489319309, Lot Number: 22KBG050,22HBX042; l. MINOR ENT SINUS PACK-LF, Item Number: DYNJ0101278F, Case UDI/GTIN: 40193489352352, Unit UDI/GTIN: 10193489352351, Lot Number: 22HDC403; m. MAJOR EAR PACK-LF, Item Number: DYNJ0101314C, Case UDI/GTIN: 40193489451093, Unit UDI/GTIN: 10193489451092, Lot Number: 22JDA679,22HDC440; n. THORACOTOMY HARPER PACK-LF, Item Number: DYNJ0161795C, Case UDI/GTIN: 40889942216629, Unit UDI/GTIN: 10889942216628, Lot Number: 22IDB179; o. FESS NSR PACK-LF, Item Number: DYNJ0381496I, Case UDI/GTIN: 40193489475310, Unit UDI/GTIN: 10193489475319, Lot Number: 22JBH235; p. ENT BASIC PACK-LF, Item Number: DYNJ0387711D, Case UDI/GTIN: 40195327270156, Unit UDI/GTIN: 10195327270155, Lot Number: 22JMI201; q. HEAD & NECK-LF, Item Number: DYNJ04437J, Case UDI/GTIN: 40193489274494, Unit UDI/GTIN: 10193489274493, Lot Number: 22JMI207; r. ENT PACK-LF, Item Number: DYNJ04591F, Case UDI/GTIN: 40193489551434, Unit UDI/GTIN: 10193489551433, Lot Number: 22JMH877; s. SINOSCOPY-LF, Item Number: DYNJ06621D, Case UDI/GTIN: 40888277854698, Unit UDI/GTIN: 10888277854697, Lot Number: 22JBM104,22HBX999; t. MAJOR HEAD/NECK PACK-LF, Item Number: DYNJ0826705N, Case UDI/GTIN: 40193489265683, Unit UDI/GTIN: 10193489265682, Lot Number: 22JMD563,22JMD586; u. NECK PACK, Item Number: DYNJ13175, Case UDI/GTIN: 40195327215782, Unit UDI/GTIN: 10195327215781, Lot Number: 22JBG041; v. HEAD & NECK PACK, Item Number: DYNJ14069B, Case UDI/GTIN: 40884389223025, Unit UDI/GTIN: 10884389223024, Lot Number: 22JBI051,22IBQ751,22IBB059; w. HEAD & NECK TRAY, Item Number: DYNJ15653J, Case UDI/GTIN: 40193489767996, Unit UDI/GTIN: 10193489767995, Lot Number: 22JBE697; x. ENT LAW PACK-LF, Item Number: DYNJ16428L, Case UDI/GTIN: 40195327084821, Unit UDI/GTIN: 10195327084820, Lot Number: 22JMD569,22HMB943; y. ENT PACK, Item Number: DYNJ17203I, Case UDI/GTIN: 40193489668170, Unit UDI/GTIN: 10193489668179, Lot Number: 22IDB986; z. NECK PACK, Item Number: DYNJ17213D, Case UDI/GTIN: 40193489668477, Unit UDI/GTIN: 10193489668476, Lot Number: 22JDA408; aa. NASAL PACK, Item Number: DYNJ17493G, Case UDI/GTIN: 40195327224425, Unit UDI/GTIN: 10195327224424, Lot Number: 22HBR581; bb. ENT PACK, Item Number: DYNJ19846J, Case UDI/GTIN: 40888277850997, Unit UDI/GTIN: 10888277850996, Lot Number: 22IBV046; cc. FREE FLAP PACK-LF, Item Number: DYNJ20495J, Case UDI/GTIN: 40195327024407, Unit UDI/GTIN: 10195327024406, Lot Number: 22JDA143; dd. TYMPANO MASTOID, Item Number: DYNJ21567A, Case UDI/GTIN: 40080196015345, Unit UDI/GTIN: 10080196015344, Lot Number: 22JBD171,22IBE475,22HBK016; ee. MINOR HEAD & NECK #40-RF, Item Number: DYNJ21948S, Case UDI/GTIN: 40195327104727, Unit UDI/GTIN: 10195327104726, Lot Number: 22JBB180,22JBC021; ff. EAR PACK, Item Number: DYNJ22136B, Case UDI/GTIN: 40193489228220, Unit UDI/GTIN: 10193489228229, Lot Number: 22KMA168; gg. E.N.T. TRAY, Item Number: DYNJ22357K, Case UDI/GTIN: 40193489926737, Unit UDI/GTIN: 10193489926736, Lot Number: 22KBB868,22JBE605,22IBD335,22HBJ735; hh. EAR PACK-LF, Item Number: DYNJ24092M, Case UDI/GTIN: 40195327024421, Unit UDI/GTIN: 10195327024420, Lot Number: 22IDA807; ii. BASIC ENT PACK-LF, Item Number: DYNJ24912K, Case UDI/GTIN: 40193489992862, Unit UDI/GTIN: 10193489992861, Lot Number: 22IBL139,22HBV866,22HBU453,22HBT633,22HBP897; jj. PLASTIC HEAD & NECK PACK, Item Number: DYNJ24941M, Case UDI/GTIN: 40889942176329, Unit UDI/GTIN: 10889942176328, Lot Number: 22IDC167; kk. EAR TRAY #10-RF, Item Number: DYNJ27428R, Case UDI/GTIN: 40195327114900, Unit UDI/GTIN: 10195327114909, Lot Number: 22JBI743; ll. HEAD & NECK ENT PACK-RF-LF, Item Number: DYNJ30604P, Case UDI/GTIN: 40193489962834, Unit UDI/GTIN: 10193489962833, Lot Number: 22IBU329,22IBU962; mm. ENT PACK, Item Number: DYNJ30988C, Case UDI/GTIN: 40889942715719, Unit UDI/GTIN: 10889942715718, Lot Number: 22IBI164; nn. ENT PACK-LF, Item Number: DYNJ31584I, Case UDI/GTIN: 40193489504416, Unit UDI/GTIN: 10193489504415, Lot Number: 22JME741,22IMG343; oo. NASAL/SEPTO PACK, Item Number: DYNJ32099, Case UDI/GTIN: 40884389092911, Unit UDI/GTIN: 10884389092910, Lot Number: 22KBA569; pp. OSC FACE LIFT PK, Item Number: DYNJ32855B, Case UDI/GTIN: 40889942465218, Unit UDI/GTIN: 10889942465217, Lot Number: 22IBH454; qq. RRMC NASAL PACK, Item Number: DYNJ33396G, Case UDI/GTIN: 40193489914574, Unit UDI/GTIN: 10193489914573, Lot Number: 22JMD009; rr. ENT PACK, Item Number: DYNJ33698D, Case UDI/GTIN: 40889942689355, Unit UDI/GTIN: 10889942689354, Lot Number: 22JBY709,22IBF415; ss. HENRYS ENT PACK, Item Number: DYNJ34093F, Case UDI/GTIN: 40193489274685, Unit UDI/GTIN: 10193489274684, Lot Number: 22JMC221; tt. ENT, Item Number: DYNJ34426I, Case UDI/GTIN: 40193489224703, Unit UDI/GTIN: 10193489224702, Lot Number: 22JMA985; uu. FACE AND NASAL PACK, Item Number: DYNJ35554B, Case UDI/GTIN: 40195327097869, Unit UDI/GTIN: 10195327097868, Lot Number: 22IBQ641; vv. NASAL PACK, Item Number: DYNJ35803A, Case UDI/GTIN: 40889942557210, Unit UDI/GTIN: 10889942557219, Lot Number: 22JBE657; ww. ENT PACK, Item Number: DYNJ36516, Case UDI/GTIN: 40884389544113, Unit UDI/GTIN: 10884389544112, Lot Number: 22HBS907; xx. SINUS ENDOSCOPY-LF, Item Number: DYNJ36720D, Case UDI/GTIN: 40195327148684, Unit UDI/GTIN: 10195327148683, Lot Number: 22JBA686; yy. OSC NASAL-NOSE PACK-LF, Item Number: DYNJ37383C, Case UDI/GTIN: 40889942465256, Unit UDI/GTIN: 10889942465255, Lot Number: 22JBA361,22HBN245,22HBN978,22HBL526; zz. ENT PACK, Item Number: DYNJ38321D, Case UDI/GTIN: 40195327103591, Unit UDI/GTIN: 10195327103590, Lot Number: 22JBQ451; aaa. FES PACK - LF, Item Number: DYNJ38730C, Case UDI/GTIN: 40195327100316, Unit UDI/GTIN: 10195327100315, Lot Number: 22JMC574; bbb. HEAD AND NECK PACK, Item Number: DYNJ38880D, Case UDI/GTIN: 40193489997331, Unit UDI/GTIN: 10193489997330, Lot Number: 22JMA087; ccc. SCRIPPS SW ENT PACK, Item Number: DYNJ39829D, Case UDI/GTIN: 40195327176571, Unit UDI/GTIN: 10195327176570, Lot Number: 22IMI295,22HME428; ddd. SCRIPPS SW EAR PACK-LF, Item Number: DYNJ39858B, Case UDI/GTIN: 40195327179466, Unit UDI/GTIN: 10195327179465, Lot Number: 22JMA176; eee. HL ENT PACK, Item Number: DYNJ40360D, Case UDI/GTIN: 40889942697176, Unit UDI/GTIN: 10889942697175, Lot Number: 22JBL587,22IBS429,22IBU440; fff. CAROTID ENDARTECTOMY PK, Item Number: DYNJ40386B, Case UDI/GTIN: 40889942215769, Unit UDI/GTIN: 10889942215768, Lot Number: 22IBP925; ggg. EAR PACK, Item Number: DYNJ40401B, Case UDI/GTIN: 40193489231527, Unit UDI/GTIN: 10193489231526, Lot Number: 22JBI621,22HBS976,22HBK587; hhh. ENT FREE FLAP, Item Number: DYNJ40403D, Case UDI/GTIN: 40193489373531, Unit UDI/GTIN: 10193489373530, Lot Number: 22IBU477,22HBT008; iii. HEAD AND NECK PACK, Item Number: DYNJ40411A, Case UDI/GTIN: 40889942216094, Unit UDI/GTIN: 10889942216093, Lot Number: 22JBI783,22IBG980,22HBI781; jjj. TRACH PACK, Item Number: DYNJ40431A, Case UDI/GTIN: 40889942215691, Unit UDI/GTIN: 10889942215690, Lot Number: 22JBP822,22HBS909; kkk. HL EAR PACK, Item Number: DYNJ40560A, Case UDI/GTIN: 40889942529897, Unit UDI/GTIN: 10889942529896, Lot Number: 22HBZ367; lll. NASAL SINUS ENDO PK, Item Number: DYNJ41024C, Case UDI/GTIN: 40889942233466, Unit UDI/GTIN: 10889942233465, Lot Number: 22IBS024; mmm. ENT PACK, Item Number: DYNJ41060A, Case UDI/GTIN: 40195327025428, Unit UDI/GTIN: 10195327025427, Lot Number: 22IBQ559,22IBL826,22IBL050; nnn. HEAD AND NECK PACK, Item Number: DYNJ41270B, Case UDI/GTIN: 40193489789080, Unit UDI/GTIN: 10193489789089, Lot Number: 22JMB156,22JMB478,22JMA301; ooo. ENT PACK, Item Number: DYNJ41327C, Case UDI/GTIN: 40193489923156, Unit UDI/GTIN: 10193489923155, Lot Number: 22JBW436,22HBI717; ppp. HEAD AND NECK PACK, Item Number: DYNJ42004B, Case UDI/GTIN: 40888277918239, Unit UDI/GTIN: 10888277918238, Lot Number: 22JMC585; qqq. ASC HEAD & NECK PACK, Item Number: DYNJ42019B, Case UDI/GTIN: 40888277938329, Unit UDI/GTIN: 10888277938328, Lot Number: 22IBM163,22HBL313; rrr. ENT PACK, Item Number: DYNJ42228B, Case UDI/GTIN: 40193489878975, Unit UDI/GTIN: 10193489878974, Lot Number: 22IMB508; sss. DEACONESS HEAD AND NECK PACK, Item Number: DYNJ42242, Case UDI/GTIN: 40884389921280, Unit UDI/GTIN: 10884389921289, Lot Number: 22HBY134,22HBZ333; ttt. ENT PACK, Item Number: DYNJ42564B, Case UDI/GTIN: 40193489685047, Unit UDI/GTIN: 10193489685046, Lot Number: 22IBC952; uuu. BEC MOHS PACK, Item Number: DYNJ43111G, Case UDI/GTIN: 40195327007615, Unit UDI/GTIN: 10195327007614, Lot Number: 22JBK014; vvv. PK,ENT-EAR, Item Number: DYNJ43700A, Case UDI/GTIN: 40193489332194, Unit UDI/GTIN: 10193489332193, Lot Number: 22HBS025,22HBP684; www. SVMMC HEAD AND NECK PACK, Item Number: DYNJ43776G, Case UDI/GTIN: 40193489989718, Unit UDI/GTIN: 10193489989717, Lot Number: 22JBG530,22JBD640; xxx. PK, ENT, Item Number: DYNJ43875B, Case UDI/GTIN: 40193489427876, Unit UDI/GTIN: 10193489427875, Lot Number: 22JBM105,22IBC196; yyy. HEAD AND NECK PACK, Item Number: DYNJ44019B, Case UDI/GTIN: 40193489795081, Unit UDI/GTIN: 10193489795080, Lot Number: 22HBY533,22HBM204; zzz. FESS PACK, Item Number: DYNJ44080A, Case UDI/GTIN: 40888277279774, Unit UDI/GTIN: 10888277279773, Lot Number: 22IBV695; aaaa. PK,ENT-SINUS, Item Number: DYNJ45036D, Case UDI/GTIN: 40193489259903, Unit UDI/GTIN: 10193489259902, Lot Number: 22JBF806,22HBG764; bbbb. NASAL/HEAD & NECK PACK, Item Number: DYNJ45078C, Case UDI/GTIN: 40195327045204, Unit UDI/GTIN: 10195327045203, Lot Number: 22JBL812,22JBL819; cccc. ENT PACK, Item Number: DYNJ45175B, Case UDI/GTIN: 40889942485216, Unit UDI/GTIN: 10889942485215, Lot Number: 22HLA901; dddd. ENT PACK, Item Number: DYNJ45260B, Case UDI/GTIN: 40193489852449, Unit UDI/GTIN: 10193489852448, Lot Number: 22JBU804; eeee. MAJOR ENT PACK, Item Number: DYNJ45576B, Case UDI/GTIN: 40195327059201, Unit UDI/GTIN: 10195327059200, Lot Number: 22JBD150,22IBS180; ffff. ENT NECK MMC PACK, Item Number: DYNJ46091G, Case UDI/GTIN: 40193489496452, Unit UDI/GTIN: 10193489496451, Lot Number: 22HDB941; gggg. HEAD AND NECK PACK, Item Number: DYNJ46216I, Case UDI/GTIN: 40195327160341, Unit UDI/GTIN: 10195327160340, Lot Number: 22JBE614,22JBE616,22IBI293; hhhh. HEAD AND NECK PACK, Item Number: DYNJ46486B, Case UDI/GTIN: 40193489472159, Unit UDI/GTIN: 10193489472158, Lot Number: 22IBH413; iiii. HEAD AND NECK PACK, Item Number: DYNJ46509G, Case UDI/GTIN: 40195327001002, Unit UDI/GTIN: 10195327001001, Lot Number: 22HMD805; jjjj. ORAL PACK, Item Number: DYNJ46541J, Case UDI/GTIN: 40195327067909, Unit UDI/GTIN: 10195327067908, Lot Number: 22HME315; kkkk. HMT THORACOSCOPY PACK, Item Number: DYNJ47230K, Case U...

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