Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. A... — FDA record Z-1067-2023

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. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART CDS PART A n. GLENNON OPEN HEART CDS o. OPEN HEART CDS p. MEMORIAL MED CTR BYPASS q. OPEN HEART PEDS r. OPEN HEART CDS-4 s. OPEN HEART t. CAB CDS u. VASCULAR CDS v. VALVE CDS w. OPEN HEART PACK-LF x. VASCULAR CDS-LF y. OPEN HEART B CDS-LF z. CRANIOTOMY CDS aa. OPEN UROLOGY CDS-LF bb. TOTAL KNEE CDS cc. LOWER EXTREMITY CDS-LF dd. LAMINECTOMY CDS ee. ENDOVASCULAR CDS ff. VASCULAR gg. VASCULAR CDS-3 hh. VASCULAR ACCESS CDS ii. ZALE PUMP CDS jj. CUH ENDOVASCULAR CDS kk. CUH MINOR VASCULAR CDS ll. FHT CVOR CABG mm. OPEN HEART CDS nn. OPEN HEART CDS oo. CAROTID ENDARTERECTOMY CDS-LF pp. PACER CDS qq. PERIPHERAL VASCULAR CDS rr. ACH OPEN HEART ss. ACH OPEN HEART tt. OPEN HEART CDS uu. VASCULAR CDS vv. CV CDS ww. OPEN HEART CABG PACK-LF xx. MAJOR VASCULAR PACK-LF yy. CARDIOVASCULAR PACK-LF zz. VASCULAR HARPER PACK-LF aaa. CABG 1 OR 2 HARPER PACK bbb. TAVR 1 PACK-LF ccc. ENDO VASCULAR PACK-LF ddd. OPEN HEART A & B PACK eee. PACEMAKER IMPLANT PACK-LF fff. PERIPHERAL VASCULAR PACK-LF ggg. PACEMAKER PACK-LF hhh. RR-NEURO VASCULAR PACK-LF iii. CARDIAC CHEST PACK 80701 jjj. OPEN HEART PACK-LF kkk. PACEMAKER PACK-LF lll. CARDIOVASCULAR PACK-LF mmm. OPEN HEART PACK A & B nnn. MINOR VASCULAR PACK ooo. OPEN HEART PACK-LF ppp. SMALL VASCULAR PACK-LF qqq. MAJOR VASCULAR PACK-LF rrr. PEDIATRIC CARDIAC PACK-LF sss. OH VALVE PACK-LF ttt. HEART OVERHEAD TABLE PACK uuu. OPEN HEART PACK vvv. PACEMAKER PACK-LF www. VASCULAR PACK-LF xxx. OPEN HEART PACK yyy. VASCULAR PACK zzz. CV BASIC SET UP PACK aaaa. UNIVERSAL OPEN HEART PACK bbbb. VASCULAR BYPASS PACK-LF cccc. BMC CABG PACK A dddd. CUSTOM CAROTID eeee. A-V FISTULA PACK-LF ffff. PERIPHERAL VASCULAR PACK-LF gggg. ECMO PACK hhhh. HEART PACK iiii. CABG PACK A&B jjjj. OPEN HEART PACK kkkk. CV A & B llll. PEDIATRIC OPEN HEART-NS-LF mmmm. PACEMAKER NORTH nnnn. OPEN HEART PACK oooo. SVMMC CORE OPEN HEART PACK-LF pppp. PACEMAKER TRAY-LF qqqq. PACEMAKER PACK rrrr. MAJOR VASCULAR-RF-LF ssss. AV FISTULA-LF tttt. PACEMAKER PACK uuuu. VASCULAR PACK vvvv. PACEMAKER wwww. MAJOR VASCULAR PACK xxxx. MAJOR VASCULAR PACK yyyy. VASCULAR PACK zzzz. PACEMAKER PACK-LF aaaaa. RRMC CABG AUXILIARY TRAY bbbbb. RRMC OPEN HEART PACK ccccc. MAJOR VASCULAR PACK ddddd. PACEMAKER PACK eeeee. PACEMAKER TRAY fffff. PACEMAKER PACK ggggg. PACEMAKER PACK hhhhh. AV FISTULA PK-LF iiiii. FHT PACER PACK jjjjj. PACEMAKER SET UP PACK kkkkk. MAJOR VASCULAR PACK lllll. PACEMAKER PACK-LF mmmmm. CAROTID PACK nnnnn. MAJOR VASCULAR PACK ooooo. VASCULAR PACK GH-LF ppppp. A-V FISTULA PACK GH-LF qqqqq. VASCULAR PACK MH-LF rrrrr. PACEMAKER PACK L J sssss. OPEN HEART ttttt. OPEN HEART SUPPLY TRAY uuuuu. PACEMAKER PACK vvvvv. PACEMAKER PACK wwwww. VASCULAR PACK xxxxx. BASIC OPEN HEART PACK A B yyyyy....
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
12,964 cases (23,379 units)
Agency-reported status
Ongoing
Source record identifier
Z-1067-2023

Open the official record

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

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilitya. EP LAB PACEMAKER PACK, Item Number: 00-401893L, Case UDI/GTIN: 40195327127887, Unit UDI/GTIN: 10195327127886, Lot Number: 22JMC769; b. OPEN HEART CDS, Item Number: CDS840016AD, Case UDI/GTIN: 40193489741842, Unit UDI/GTIN: 10193489741841, Lot Number: 22KBB889; c. OPEN HEART CDS, Item Number: CDS840023T, Case UDI/GTIN: 40193489682060, Unit UDI/GTIN: 10193489682069, Lot Number: 22JBU353,22JBT770; d. AAA CDS, Item Number: CDS840076AC, Case UDI/GTIN: 40195327209620, Unit UDI/GTIN: 10195327209629, Lot Number: 22KBE518; e. OPEN HEART CDS, Item Number: CDS840094N, Case UDI/GTIN: 40195327089512, Unit UDI/GTIN: 10195327089511, Lot Number: 22JBI258,22IBF817; f. PACEMAKER CDS, Item Number: CDS840162V, Case UDI/GTIN: 40193489480628, Unit UDI/GTIN: 10193489480627, Lot Number: 22KBG388,22IBP339; g. HEART CDS, Item Number: CDS840179M, Case UDI/GTIN: 40889942894001, Unit UDI/GTIN: 10889942894000, Lot Number: 22JBJ710,22IBQ944; h. VALVE PACK, Item Number: CDS840187T, Case UDI/GTIN: 40193489816465, Unit UDI/GTIN: 10193489816464, Lot Number: 22JMG653; i. OPEN HEART CDS-3, Item Number: CDS840246N, Case UDI/GTIN: 40889942217428, Unit UDI/GTIN: 10889942217427, Lot Number: 22JLB009,22JLA126,22ILB075; j. OPEN HEART PACK, Item Number: CDS840332Y, Case UDI/GTIN: 40195327259298, Unit UDI/GTIN: 10195327259297, Lot Number: 22KLA079; k. OPEN HEART PACK, Item Number: CDS840393M, Case UDI/GTIN: 40195327188543, Unit UDI/GTIN: 10195327188542, Lot Number: 22KBD842; l. OPEN HEART ADULT, Item Number: CDS840396X, Case UDI/GTIN: 40193489461917, Unit UDI/GTIN: 10193489461916, Lot Number: 22JBG072,22JBG077,22JBG079; m. OPEN HEART CDS PART A, Item Number: CDS840402AG, Case UDI/GTIN: 40195327255115, Unit UDI/GTIN: 10195327255114, Lot Number: 22JLA474; n. GLENNON OPEN HEART CDS, Item Number: CDS840412N, Case UDI/GTIN: 40195327072231, Unit UDI/GTIN: 10195327072230, Lot Number: 22JBG206; o. OPEN HEART CDS, Item Number: CDS840483K, Case UDI/GTIN: 40888277749796, Unit UDI/GTIN: 10888277749795, Lot Number: 22IBR228; p. MEMORIAL MED CTR BYPASS, Item Number: CDS901660, Case UDI/GTIN: 40888277814111, Unit UDI/GTIN: 10888277814110, Lot Number: 22KBA999,22JBL553; q. OPEN HEART PEDS, Item Number: CDS981050Q, Case UDI/GTIN: 40889942864660, Unit UDI/GTIN: 10889942864669, Lot Number: 22JBH010,22IBC746,22IBC748; r. OPEN HEART CDS-4, Item Number: CDS981159J, Case UDI/GTIN: 40889942215110, Unit UDI/GTIN: 10889942215119, Lot Number: 22JLA895,22ILA228; s. OPEN HEART, Item Number: CDS981161AB, Case UDI/GTIN: 40193489817462, Unit UDI/GTIN: 10193489817461, Lot Number: 22JBT785; t. CAB CDS, Item Number: CDS981533G, Case UDI/GTIN: 40195327171422, Unit UDI/GTIN: 10195327171421, Lot Number: 22JBW502; u. VASCULAR CDS, Item Number: CDS981545F, Case UDI/GTIN: 40193489975407, Unit UDI/GTIN: 10193489975406, Lot Number: 22JBU076,22JBU077; v. VALVE CDS, Item Number: CDS981551D, Case UDI/GTIN: 40195327171439, Unit UDI/GTIN: 10195327171438, Lot Number: 22JBR297,22IBS787; w. OPEN HEART PACK-LF, Item Number: CDS981662J, Case UDI/GTIN: 40195327014538, Unit UDI/GTIN: 10195327014537, Lot Number: 22JBV196; x. VASCULAR CDS-LF, Item Number: CDS982412O, Case UDI/GTIN: 40195327212378, Unit UDI/GTIN: 10195327212377, Lot Number: 22IBB001,22IBB003; y. OPEN HEART B CDS-LF, Item Number: CDS982423L, Case UDI/GTIN: 40193489419802, Unit UDI/GTIN: 10193489419801, Lot Number: 22JBQ337; z. CRANIOTOMY CDS, Item Number: CDS982480P, Case UDI/GTIN: 40195327195671, Unit UDI/GTIN: 10195327195670, Lot Number: 22IDB602; aa. OPEN UROLOGY CDS-LF, Item Number: CDS982482I, Case UDI/GTIN: 40195327071777, Unit UDI/GTIN: 10195327071776, Lot Number: 22JDB005,22IDB497; bb. TOTAL KNEE CDS, Item Number: CDS982486M, Case UDI/GTIN: 40195327092345, Unit UDI/GTIN: 10195327092344, Lot Number: 22KDA380; cc. LOWER EXTREMITY CDS-LF, Item Number: CDS982489J, Case UDI/GTIN: 40195327090754, Unit UDI/GTIN: 10195327090753, Lot Number: 22JDB330,22IDB911; dd. LAMINECTOMY CDS, Item Number: CDS982491Q, Case UDI/GTIN: 40195327195725, Unit UDI/GTIN: 10195327195724, Lot Number: 22JDB539,22JDA137; ee. ENDOVASCULAR CDS, Item Number: CDS982659M, Case UDI/GTIN: 40193489204187, Unit UDI/GTIN: 10193489204186, Lot Number: 22KLA219,22JLB019,22ILB085; ff. VASCULAR, Item Number: CDS982699J, Case UDI/GTIN: 40193489418102, Unit UDI/GTIN: 10193489418101, Lot Number: 22KBB744,22KBB751,22KBB749; gg. VASCULAR CDS-3, Item Number: CDS983002D, Case UDI/GTIN: 40889942000433, Unit UDI/GTIN: 10889942000432, Lot Number: 22JLA875,22ILA255; hh. VASCULAR ACCESS CDS, Item Number: CDS983105D, Case UDI/GTIN: 40193489635509, Unit UDI/GTIN: 10193489635508, Lot Number: 22JBC333; ii. ZALE PUMP CDS, Item Number: CDS983187G, Case UDI/GTIN: 40195327258529, Unit UDI/GTIN: 10195327258528, Lot Number: 22JBX916; jj. CUH ENDOVASCULAR CDS, Item Number: CDS983192G, Case UDI/GTIN: 40193489699068, Unit UDI/GTIN: 10193489699067, Lot Number: 22JBF027,22HBY314; kk. CUH MINOR VASCULAR CDS, Item Number: CDS983196G, Case UDI/GTIN: 40195327164660, Unit UDI/GTIN: 10195327164669, Lot Number: 22JBT201,22IBB523; ll. FHT CVOR CABG, Item Number: CDS983346I, Case UDI/GTIN: 40193489929332, Unit UDI/GTIN: 10193489929331, Lot Number: 22IBU546; mm. OPEN HEART CDS, Item Number: CDS983451Q, Case UDI/GTIN: 40195327165186, Unit UDI/GTIN: 10195327165185, Lot Number: 22JBY402; nn. OPEN HEART CDS, Item Number: CDS983513F, Case UDI/GTIN: 40193489843720, Unit UDI/GTIN: 10193489843729, Lot Number: 22IBD426; oo. CAROTID ENDARTERECTOMY CDS-LF, Item Number: CDS983637I, Case UDI/GTIN: 40195327228126, Unit UDI/GTIN: 10195327228125, Lot Number: 22KBC672; pp. PACER CDS, Item Number: CDS983686I, Case UDI/GTIN: 40193489852982, Unit UDI/GTIN: 10193489852981, Lot Number: 22JBL438,22IBU735; qq. PERIPHERAL VASCULAR CDS, Item Number: CDS983723I, Case UDI/GTIN: 40195327228157, Unit UDI/GTIN: 10195327228156, Lot Number: 22JBR360,22IBP608; rr. ACH OPEN HEART, Item Number: CDS983773I, Case UDI/GTIN: 40193489847124, Unit UDI/GTIN: 10193489847123, Lot Number: 22IBJ338; ss. ACH OPEN HEART, Item Number: CDS983773J, Case UDI/GTIN: 40195327233618, Unit UDI/GTIN: 10195327233617, Lot Number: 22JBH775; tt. OPEN HEART CDS, Item Number: CDS984355G, Case UDI/GTIN: 40193489484633, Unit UDI/GTIN: 10193489484632, Lot Number: 22JLB146,22ILB092,22ILA721; uu. VASCULAR CDS, Item Number: CDS985215D, Case UDI/GTIN: 40195327110797, Unit UDI/GTIN: 10195327110796, Lot Number: 22IBR023,22IBA153; vv. CV CDS, Item Number: CDS985395D, Case UDI/GTIN: 40193489859714, Unit UDI/GTIN: 10193489859713, Lot Number: 22JBI301,22IBU577; ww. OPEN HEART CABG PACK-LF, Item Number: DYNJ0149567C, Case UDI/GTIN: 40195327235520, Unit UDI/GTIN: 10195327235529, Lot Number: 22IBD436; xx. MAJOR VASCULAR PACK-LF, Item Number: DYNJ0151111B, Case UDI/GTIN: 40889942050797, Unit UDI/GTIN: 10889942050796, Lot Number: 22IDB491,22IDA147; yy. CARDIOVASCULAR PACK-LF, Item Number: DYNJ0160327B, Case UDI/GTIN: 40889942051770, Unit UDI/GTIN: 10889942051779, Lot Number: 22JDA346; zz. VASCULAR HARPER PACK-LF, Item Number: DYNJ0160636F, Case UDI/GTIN: 40193489205566, Unit UDI/GTIN: 10193489205565, Lot Number: 22IDA733,22HDC250; aaa. CABG 1 OR 2 HARPER PACK, Item Number: DYNJ0160742D, Case UDI/GTIN: 40195327005970, Unit UDI/GTIN: 10195327005979, Lot Number: 22IDB925,22HDA618; bbb. TAVR 1 PACK-LF, Item Number: DYNJ0170415G, Case UDI/GTIN: 40195327167685, Unit UDI/GTIN: 10195327167684, Lot Number: 22HMD027; ccc. ENDO VASCULAR PACK-LF, Item Number: DYNJ0236704N, Case UDI/GTIN: 40193489720670, Unit UDI/GTIN: 10193489720679, Lot Number: 22IME561; ddd. OPEN HEART A & B PACK, Item Number: DYNJ0236832P, Case UDI/GTIN: 40193489404631, Unit UDI/GTIN: 10193489404630, Lot Number: 22HMB796; eee. PACEMAKER IMPLANT PACK-LF, Item Number: DYNJ0373237M, Case UDI/GTIN: 40193489369015, Unit UDI/GTIN: 10193489369014, Lot Number: 22JBO014; fff. PERIPHERAL VASCULAR PACK-LF, Item Number: DYNJ0375688L, Case UDI/GTIN: 40193489724258, Unit UDI/GTIN: 10193489724257, Lot Number: 22JBI091; ggg. PACEMAKER PACK-LF, Item Number: DYNJ0378729F, Case UDI/GTIN: 40888277763310, Unit UDI/GTIN: 10888277763319, Lot Number: 22IMB260; hhh. RR-NEURO VASCULAR PACK-LF, Item Number: DYNJ0394874L, Case UDI/GTIN: 40193489800006, Unit UDI/GTIN: 10193489800005, Lot Number: 22GLB222; iii. CARDIAC CHEST PACK 80701, Item Number: DYNJ04439N, Case UDI/GTIN: 40195327160303, Unit UDI/GTIN: 10195327160302, Lot Number: 22JBI819; jjj. OPEN HEART PACK-LF, Item Number: DYNJ04506V, Case UDI/GTIN: 40193489510318, Unit UDI/GTIN: 10193489510317, Lot Number: 22JMC546; kkk. PACEMAKER PACK-LF, Item Number: DYNJ04516N, Case UDI/GTIN: 40888277744517, Unit UDI/GTIN: 10888277744516, Lot Number: 22JMH689,22IMF834; lll. CARDIOVASCULAR PACK-LF, Item Number: DYNJ04676T, Case UDI/GTIN: 40193489805742, Unit UDI/GTIN: 10193489805741, Lot Number: 22JMD285; mmm. OPEN HEART PACK A & B, Item Number: DYNJ04822R, Case UDI/GTIN: 40195327188178, Unit UDI/GTIN: 10195327188177, Lot Number: 22JBC142; nnn. MINOR VASCULAR PACK, Item Number: DYNJ04852O, Case UDI/GTIN: 40193489303897, Unit UDI/GTIN: 10193489303896, Lot Number: 22IMF450; ooo. OPEN HEART PACK-LF, Item Number: DYNJ0530912AK, Case UDI/GTIN: 40195327167661, Unit UDI/GTIN: 10195327167660, Lot Number: 22IBO170; ppp. SMALL VASCULAR PACK-LF, Item Number: DYNJ0536987AC, Case UDI/GTIN: 40195327170616, Unit UDI/GTIN: 10195327170615, Lot Number: 22JMF083; qqq. MAJOR VASCULAR PACK-LF, Item Number: DYNJ0536993AI, Case UDI/GTIN: 40195327167630, Unit UDI/GTIN: 10195327167639, Lot Number: 22IBG292; rrr. PEDIATRIC CARDIAC PACK-LF, Item Number: DYNJ0537013AA, Case UDI/GTIN: 40195327167678, Unit UDI/GTIN: 10195327167677, Lot Number: 22JMC081; sss. OH VALVE PACK-LF, Item Number: DYNJ0541850O, Case UDI/GTIN: 40195327167654, Unit UDI/GTIN: 10195327167653, Lot Number: 22IBS422; ttt. HEART OVERHEAD TABLE PACK, Item Number: DYNJ0778508I, Case UDI/GTIN: 40195327049462, Unit UDI/GTIN: 10195327049461, Lot Number: 22IME042; uuu. OPEN HEART PACK, Item Number: DYNJ0826299T, Case UDI/GTIN: 40193489377980, Unit UDI/GTIN: 10193489377989, Lot Number: 22IBB762,22HBO328; vvv. PACEMAKER PACK-LF, Item Number: DYNJ0826630L, Case UDI/GTIN: 40195327177073, Unit UDI/GTIN: 10195327177072, Lot Number: 22IMH402,22IMF458; www. VASCULAR PACK-LF, Item Number: DYNJ0901358J, Case UDI/GTIN: 40195327156559, Unit UDI/GTIN: 10195327156558, Lot Number: 22IDA821; xxx. OPEN HEART PACK, Item Number: DYNJ0911264O, Case UDI/GTIN: 40195327124329, Unit UDI/GTIN: 10195327124328, Lot Number: 22IBQ743,22HBY040; yyy. VASCULAR PACK, Item Number: DYNJ14078F, Case UDI/GTIN: 40193489927840, Unit UDI/GTIN: 10193489927849, Lot Number: 22IBI839; zzz. CV BASIC SET UP PACK, Item Number: DYNJ14224F, Case UDI/GTIN: 40193489927680, Unit UDI/GTIN: 10193489927689, Lot Number: 22JBS669; aaaa. UNIVERSAL OPEN HEART PACK, Item Number: DYNJ14225F, Case UDI/GTIN: 40888277944078, Unit UDI/GTIN: 10888277944077, Lot Number: 22HBG261; bbbb. VASCULAR BYPASS PACK-LF, Item Number: DYNJ17470G, Case UDI/GTIN: 40195327224555, Unit UDI/GTIN: 10195327224554, Lot Number: 22JBW106,22JBD564,22IBM206; cccc. BMC CABG PACK A, Item Number: DYNJ17475J, Case UDI/GTIN: 40195327224807, Unit UDI/GTIN: 10195327224806, Lot Number: 22IBN857,22IBA835,22HBO577,22HBP255; dddd. CUSTOM CAROTID, Item Number: DYNJ20266K, Case UDI/GTIN: 40195327052943, Unit UDI/GTIN: 10195327052942, Lot Number: 22IBJ739; eeee. A-V FISTULA PACK-LF, Item Number: DYNJ20502P, Case UDI/GTIN: 40195327024414, Unit UDI/GTIN: 10195327024413, Lot Number: 22JDB304,22IDC077,22IDA958,22IDA175; ffff. PERIPHERAL VASCULAR PACK-LF, Item Number: DYNJ20503P, Case UDI/GTIN: 40195327024605, Unit UDI/GTIN: 10195327024604, Lot Number: 22IDA018; gggg. ECMO PACK, Item Number: DYNJ21245N, Case UDI/GTIN: 40193489935708, Unit UDI/GTIN: 10193489935707, Lot Number: 22JBM468,22HBQ114; hhhh. HEART PACK, Item Number: DYNJ21246P, Case UDI/GTIN: 40193489935715, Unit UDI/GTIN: 10193489935714, Lot Number: 22HBK069; iiii. CABG PACK A&B, Item Number: DYNJ21971AD, Case UDI/GTIN: 40195327227051, Unit UDI/GTIN: 10195327227050, Lot Number: 22JDA281,22IDA306; jjjj...

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.

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