Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS ...
FDA Device Recall #Z-1088-2023 — Class II — November 17, 2022
Recall Summary
| Recall Number | Z-1088-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 17, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 6,782 cases (15,253 units) |
Product Description
Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l. U H S NEURO PACK SC m. NEURO PACK-CELEBRATION n. NEURO PACK o. NEURO BASIN PACK-LF p. NEURO PACK q. MAJOR NEURO PK-LF r. NINOR NEURO PK-LF s. NEURO VP SHUNT/VAGAL NERVE-RF t. NEURO PACK-LF u. NEURO PACK v. CRANIOTOMY w. PEDIATRIC NEURO PACK x. NEURO MATRIX PACK y. ACOUSTIC NEUROMA PACK-LF z. MAJOR NEURO PACK-LF aa. SCRIPPS SW NEURO PACK-LF bb. NEURO PACK cc. GENERAL PACK dd. NEURO PK ee. NEURO PACK ff. NEURO PACK gg. NEURO PACK hh. NEURO PACK-LF ii. NEURO PACK jj. NEURO PACK kk. NEURO PACK ll. NEURO PACK mm. CRANIOTOMY PACK nn. PK, NEURO-MINOR oo. NEURO PACK pp. NEURO PACK qq. NEURO PACK rr. PK, NEURO-MINOR ss. NEURO BASIC tt. NEURO BASIC uu. CRANIOTOMY PACK (CRSJE)227-LF vv. NEURO PACK ww. NEURO PACK xx. NEURO CRANI PACK yy. NEURO PACK zz. NEURO TRAY-LF aaa. NEURO PACK bbb. WH NEURO PACK ccc. RFT ISC-N NEURO PACK ddd. NEURO-LF eee. NEURO PACK fff. NEURO LUMBAR PACK ggg. NEURO FUSION PACK-LF hhh. NEURO CERVICAL PACK iii. NEURO PACK jjj. VP SHUNT PACK kkk. NEURO BASIC PACK lll. NEURO PACK mmm. CHRISTUS CHILDRENS NEURO PK nnn. CHRISTUS CHILDRENS VP SHUNT PK ooo. RF NEURO-SHUNT PACK ppp. NEURO PACK qqq. NEURO PACK rrr. NEURO ST DAVIDS MEDICAL CTR sss. GIO NEURO PACK ttt. NEURO KIT uuu. DISCECTOMY PACK vvv. NEURO PACK www. BASIC NEURO PACK-LF xxx. NEURO PACK yyy. NEURO PACK zzz. NEURO aaaa. NEURO bbbb. FHCW NEURO PACK cccc. NEURO FERREE dddd. NEURO eeee. NEURO PACK CW ffff. NEURO gggg. FHT NEURO hhhh. NEURO BASIC iiii. NEURO LUMBAR jjjj. NCH NEURO kkkk. TAVI llll. CHN OR NEURO mmmm. NEURO PACK-LF nnnn. NEURO-CRANI-LF
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Lot / Code Information
a. AV SHUNT CDS, Item Number: CDS983098D, Case UDI/GTIN: 40195327191307, Unit UDI/GTIN: 10195327191306, Lot Number: 22IBD957; b. ZALE V-P SHUNT CDS, Item Number: CDS983186J, Case UDI/GTIN: 40195327105625, Unit UDI/GTIN: 10195327105624, Lot Number: 22IBT194; c. NEURO CDS-LF, Item Number: CDS985289, Case UDI/GTIN: 40888277050502, Unit UDI/GTIN: 10888277050501, Lot Number: 22JBH363,22IBF823,22IBD861; d. MAJOR NEURO, Item Number: CDS985548N, Case UDI/GTIN: 40195327033256, Unit UDI/GTIN: 10195327033255, Lot Number: 22JBR391,22JBI641,22GBG964; e. NEURO PACK-LF, Item Number: DYNJ0038440B, Case UDI/GTIN: 40193489506885, Unit UDI/GTIN: 10193489506884, Lot Number: 22IME936; f. CUSTOM NEURO PACK-LF, Item Number: DYNJ0190156F, Case UDI/GTIN: 40193489357531, Unit UDI/GTIN: 10193489357530, Lot Number: 22JMA809; g. NEURO PACK-LF, Item Number: DYNJ0367094L, Case UDI/GTIN: 40889942123859, Unit UDI/GTIN: 10889942123858, Lot Number: 22IMI193,22HMF079; h. NEURO PACK-LF, Item Number: DYNJ0374024J, Case UDI/GTIN: 40889942902119, Unit UDI/GTIN: 10889942902118, Lot Number: 22HBW509,22HBX254,22HBV379; i. NEURO PACK-LF, Item Number: DYNJ04596K, Case UDI/GTIN: 40193489301343, Unit UDI/GTIN: 10193489301342, Lot Number: 22JMA062,22IMB264; j. NEURO PACK-LF, Item Number: DYNJ04671Q, Case UDI/GTIN: 40888277743312, Unit UDI/GTIN: 10888277743311, Lot Number: 22HMC512; k. NEURO/LAMINECTOMY BASIN PK-LF, Item Number: DYNJ0781823K, Case UDI/GTIN: 40193489919197, Unit UDI/GTIN: 10193489919196, Lot Number: 22JMB723,22HMD049; l. U H S NEURO PACK SC, Item Number: DYNJ07952J, Case UDI/GTIN: 40889942607953, Unit UDI/GTIN: 10889942607952, Lot Number: 22JBO711; m. NEURO PACK-CELEBRATION, Item Number: DYNJ14032, Case UDI/GTIN: 40080196777953, Unit UDI/GTIN: 10080196777952, Lot Number: 22KBB459,22IBU513; n. NEURO PACK, Item Number: DYNJ14077I, Case UDI/GTIN: 40193489927673, Unit UDI/GTIN: 10193489927672, Lot Number: 22JBJ480; o. NEURO BASIN PACK-LF, Item Number: DYNJ16473K, Case UDI/GTIN: 40193489920865, Unit UDI/GTIN: 10193489920864, Lot Number: 22JDC136,22HDC097; p. NEURO PACK, Item Number: DYNJ19847M, Case UDI/GTIN: 40888277792303, Unit UDI/GTIN: 10888277792302, Lot Number: 22JBY146,22JBK343; q. MAJOR NEURO PK-LF, Item Number: DYNJ21243M, Case UDI/GTIN: 40193489225236, Unit UDI/GTIN: 10193489225235, Lot Number: 22HBY346; r. NINOR NEURO PK-LF, Item Number: DYNJ21244N, Case UDI/GTIN: 40193489225229, Unit UDI/GTIN: 10193489225228, Lot Number: 22JBV649; s. NEURO VP SHUNT/VAGAL NERVE-RF, Item Number: DYNJ21925S, Case UDI/GTIN: 40195327105021, Unit UDI/GTIN: 10195327105020, Lot Number: 22IBS173; t. NEURO PACK-LF, Item Number: DYNJ25097F, Case UDI/GTIN: 40889942871576, Unit UDI/GTIN: 10889942871575, Lot Number: 22JBK228,22JBI289; u. NEURO PACK, Item Number: DYNJ30477K, Case UDI/GTIN: 40193489912679, Unit UDI/GTIN: 10193489912678, Lot Number: 22JMG210,22HMB824; v. CRANIOTOMY, Item Number: DYNJ35349C, Case UDI/GTIN: 40888277858061, Unit UDI/GTIN: 10888277858060, Lot Number: 22HBP277; w. PEDIATRIC NEURO PACK, Item Number: DYNJ35480F, Case UDI/GTIN: 40193489803694, Unit UDI/GTIN: 10193489803693, Lot Number: 22JMB626,22IMF848,22IMC064; x. NEURO MATRIX PACK, Item Number: DYNJ36594F, Case UDI/GTIN: 40193489928991, Unit UDI/GTIN: 10193489928990, Lot Number: 22JBF140,22IBG656,22HBM006; y. ACOUSTIC NEUROMA PACK-LF, Item Number: DYNJ37741B, Case UDI/GTIN: 40195327081332, Unit UDI/GTIN: 10195327081331, Lot Number: 22JMC172,22HMD563; z. MAJOR NEURO PACK-LF, Item Number: DYNJ37751B, Case UDI/GTIN: 40195327082209, Unit UDI/GTIN: 10195327082208, Lot Number: 22JMF991; aa. SCRIPPS SW NEURO PACK-LF, Item Number: DYNJ39836F, Case UDI/GTIN: 40195327176717, Unit UDI/GTIN: 10195327176716, Lot Number: 22JME760,22HMI113,22HMD278,22GMB860; bb. NEURO PACK, Item Number: DYNJ41225B, Case UDI/GTIN: 40193489675673, Unit UDI/GTIN: 10193489675672, Lot Number: 22JBX284; cc. GENERAL PACK, Item Number: DYNJ41249C, Case UDI/GTIN: 40888277882035, Unit UDI/GTIN: 10888277882034, Lot Number: 22IBG204; dd. NEURO PK, Item Number: DYNJ41276F, Case UDI/GTIN: 40195327204021, Unit UDI/GTIN: 10195327204020, Lot Number: 22JMG029,22HMD792; ee. NEURO PACK, Item Number: DYNJ41579A, Case UDI/GTIN: 40888277935274, Unit UDI/GTIN: 10888277935273, Lot Number: 22IBA883; ff. NEURO PACK, Item Number: DYNJ41633B, Case UDI/GTIN: 40888277934918, Unit UDI/GTIN: 10888277934917, Lot Number: 22IBU441,22HBX309,22HBP962; gg. NEURO PACK, Item Number: DYNJ42484, Case UDI/GTIN: 40884389924045, Unit UDI/GTIN: 10884389924044, Lot Number: 22IBH224; hh. NEURO PACK-LF, Item Number: DYNJ42844D, Case UDI/GTIN: 40193489880565, Unit UDI/GTIN: 10193489880564, Lot Number: 22JBT933,22HBZ336; ii. NEURO PACK, Item Number: DYNJ43177B, Case UDI/GTIN: 40889942884392, Unit UDI/GTIN: 10889942884391, Lot Number: 22IMC154; jj. NEURO PACK, Item Number: DYNJ43856C, Case UDI/GTIN: 40195327200238, Unit UDI/GTIN: 10195327200237, Lot Number: 22IBS432,22HBP196; kk. NEURO PACK, Item Number: DYNJ43934A, Case UDI/GTIN: 40193489733601, Unit UDI/GTIN: 10193489733600, Lot Number: 22IMD151; ll. NEURO PACK, Item Number: DYNJ44014B, Case UDI/GTIN: 40889942278917, Unit UDI/GTIN: 10889942278916, Lot Number: 22KMA329,22JMC591; mm. CRANIOTOMY PACK, Item Number: DYNJ44040, Case UDI/GTIN: 40888277085955, Unit UDI/GTIN: 10888277085954, Lot Number: 22HBV694; nn. PK, NEURO-MINOR, Item Number: DYNJ45053C, Case UDI/GTIN: 40195327248759, Unit UDI/GTIN: 10195327248758, Lot Number: 22IBT923; oo. NEURO PACK, Item Number: DYNJ45267B, Case UDI/GTIN: 40193489852425, Unit UDI/GTIN: 10193489852424, Lot Number: 22HBV288; pp. NEURO PACK, Item Number: DYNJ46232A, Case UDI/GTIN: 40889942153450, Unit UDI/GTIN: 10889942153459, Lot Number: 22JBW760; qq. NEURO PACK, Item Number: DYNJ46238C, Case UDI/GTIN: 40888277737304, Unit UDI/GTIN: 10888277737303, Lot Number: 22IBG653,22HBX977,22HBX980; rr. PK, NEURO-MINOR, Item Number: DYNJ46282A, Case UDI/GTIN: 40193489310475, Unit UDI/GTIN: 10193489310474, Lot Number: 22JBO162,22JBO223,22IBJ968; ss. NEURO BASIC, Item Number: DYNJ46424D, Case UDI/GTIN: 40193489710350, Unit UDI/GTIN: 10193489710359, Lot Number: 22IBD742; tt. NEURO BASIC, Item Number: DYNJ46424F, Case UDI/GTIN: 40195327260683, Unit UDI/GTIN: 10195327260682, Lot Number: 22JBB084; uu. CRANIOTOMY PACK (CRSJE)227-LF, Item Number: DYNJ47487A, Case UDI/GTIN: 40889942106241, Unit UDI/GTIN: 10889942106240, Lot Number: 22JMF056,22HMD080; vv. NEURO PACK, Item Number: DYNJ48765, Case UDI/GTIN: 40888277943491, Unit UDI/GTIN: 10888277943490, Lot Number: 22IBQ098,22IBE948,22HME671; ww. NEURO PACK, Item Number: DYNJ49004, Case UDI/GTIN: 40888277810809, Unit UDI/GTIN: 10888277810808, Lot Number: 22JMI090,22JMC180,22IMD860,22HMD361; xx. NEURO CRANI PACK, Item Number: DYNJ49358, Case UDI/GTIN: 40888277847096, Unit UDI/GTIN: 10888277847095, Lot Number: 22JBQ325; yy. NEURO PACK, Item Number: DYNJ49529B, Case UDI/GTIN: 40889942203780, Unit UDI/GTIN: 10889942203789, Lot Number: 22IBS439,22IBE973; zz. NEURO TRAY-LF, Item Number: DYNJ49580C, Case UDI/GTIN: 40193489231206, Unit UDI/GTIN: 10193489231205, Lot Number: 22IBN986; aaa. NEURO PACK, Item Number: DYNJ50292F, Case UDI/GTIN: 40193489834438, Unit UDI/GTIN: 10193489834437, Lot Number: 22JBV778,22JBC215; bbb. WH NEURO PACK, Item Number: DYNJ50569, Case UDI/GTIN: 40889942008453, Unit UDI/GTIN: 10889942008452, Lot Number: 22JBQ343; ccc. RFT ISC-N NEURO PACK, Item Number: DYNJ50852G, Case UDI/GTIN: 40193489565028, Unit UDI/GTIN: 10193489565027, Lot Number: 22JMA472,22HMD933; ddd. NEURO-LF, Item Number: DYNJ52055F, Case UDI/GTIN: 40195327096336, Unit UDI/GTIN: 10195327096335, Lot Number: 22IBD221; eee. NEURO PACK, Item Number: DYNJ52243B, Case UDI/GTIN: 40889942829294, Unit UDI/GTIN: 10889942829293, Lot Number: 22IMF259; fff. NEURO LUMBAR PACK, Item Number: DYNJ53664D, Case UDI/GTIN: 40193489232067, Unit UDI/GTIN: 10193489232066, Lot Number: 22IBH772; ggg. NEURO FUSION PACK-LF, Item Number: DYNJ54360C, Case UDI/GTIN: 40193489815451, Unit UDI/GTIN: 10193489815450, Lot Number: 22IBR798; hhh. NEURO CERVICAL PACK, Item Number: DYNJ55737A, Case UDI/GTIN: 40889942943266, Unit UDI/GTIN: 10889942943265, Lot Number: 22JMB645; iii. NEURO PACK, Item Number: DYNJ57663, Case UDI/GTIN: 40889942763840, Unit UDI/GTIN: 10889942763849, Lot Number: 22JBW468,22IBB120; jjj. VP SHUNT PACK, Item Number: DYNJ59702F, Case UDI/GTIN: 40195327200269, Unit UDI/GTIN: 10195327200268, Lot Number: 22JBM510; kkk. NEURO BASIC PACK, Item Number: DYNJ60054, Case UDI/GTIN: 40888277797988, Unit UDI/GTIN: 10888277797987, Lot Number: 22KBA488,22JBR179,22IBI219; lll. NEURO PACK, Item Number: DYNJ60792C, Case UDI/GTIN: 40195327126965, Unit UDI/GTIN: 10195327126964, Lot Number: 22HBN525; mmm. CHRISTUS CHILDRENS NEURO PK, Item Number: DYNJ61168B, Case UDI/GTIN: 40195327118946, Unit UDI/GTIN: 10195327118945, Lot Number: 22IBR244,22HBY116,22HBV048; nnn. CHRISTUS CHILDRENS VP SHUNT PK, Item Number: DYNJ61174B, Case UDI/GTIN: 40195327119486, Unit UDI/GTIN: 10195327119485, Lot Number: 22JLA318,22ILA429,22HLB020; ooo. RF NEURO-SHUNT PACK, Item Number: DYNJ61387A, Case UDI/GTIN: 40193489444149, Unit UDI/GTIN: 10193489444148, Lot Number: 22IMG094,22IMG100; ppp. NEURO PACK, Item Number: DYNJ61419A, Case UDI/GTIN: 40193489676366, Unit UDI/GTIN: 10193489676365, Lot Number: 22JMH617; qqq. NEURO PACK, Item Number: DYNJ61740F, Case UDI/GTIN: 40195327238811, Unit UDI/GTIN: 10195327238810, Lot Number: 22IBF063; rrr. NEURO ST DAVIDS MEDICAL CTR, Item Number: DYNJ61998, Case UDI/GTIN: 40193489615013, Unit UDI/GTIN: 10193489615012, Lot Number: 22IBF340,22HBX978,22HBX979; sss. GIO NEURO PACK, Item Number: DYNJ62652A, Case UDI/GTIN: 40193489224581, Unit UDI/GTIN: 10193489224580, Lot Number: 22IBK347; ttt. NEURO KIT, Item Number: DYNJ62854C, Case UDI/GTIN: 40193489426985, Unit UDI/GTIN: 10193489426984, Lot Number: 22IBU624; uuu. DISCECTOMY PACK, Item Number: DYNJ67835, Case UDI/GTIN: 40193489444811, Unit UDI/GTIN: 10193489444810, Lot Number: 22IBV281; vvv. NEURO PACK, Item Number: DYNJ68898C, Case UDI/GTIN: 40195327060283, Unit UDI/GTIN: 10195327060282, Lot Number: 22IMI313; www. BASIC NEURO PACK-LF, Item Number: DYNJ81867, Case UDI/GTIN: 40195327153305, Unit UDI/GTIN: 10195327153304, Lot Number: 22HMC380,22HMB884; xxx. NEURO PACK, Item Number: DYNJ82633, Case UDI/GTIN: 40195327199556, Unit UDI/GTIN: 10195327199555, Lot Number: 22HBM512; yyy. NEURO PACK, Item Number: DYNJ83029, Case UDI/GTIN: 40195327228980, Unit UDI/GTIN: 10195327228989, Lot Number: 22JBV413; zzz. NEURO, Item Number: DYNJ900904J, Case UDI/GTIN: 40193489906616, Unit UDI/GTIN: 10193489906615, Lot Number: 22JBY355,22KBC323; aaaa. NEURO, Item Number: DYNJ901680G, Case UDI/GTIN: 40193489308083, Unit UDI/GTIN: 10193489308082, Lot Number: 22KBA252,22JBE473; bbbb. FHCW NEURO PACK, Item Number: DYNJ901990C, Case UDI/GTIN: 40193489932363, Unit UDI/GTIN: 10193489932362, Lot Number: 22JBL441,22IBV599; cccc. NEURO FERREE, Item Number: DYNJ902388K, Case UDI/GTIN: 40195327224753, Unit UDI/GTIN: 10195327224752, Lot Number: 22IBS547; dddd. NEURO, Item Number: DYNJ902585A, Case UDI/GTIN: 40193489985413, Unit UDI/GTIN: 10193489985412, Lot Number: 22IDA639; eeee. NEURO PACK CW, Item Number: DYNJ903091B, Case UDI/GTIN: 40193489961530, Unit UDI/GTIN: 10193489961539, Lot Number: 22IBU575,22IBU579; ffff. NEURO, Item Number: DYNJ903519A, Case UDI/GTIN: 40889942594215, Unit UDI/GTIN: 10889942594214, Lot Number: 22JBU552; gggg. FHT NEURO, Item Number: DYNJ903566C, Case UDI/GTIN: 40193489932103, Unit UDI/GTIN: 10193489932102, Lot Number: 22JBB451; hhhh. NEURO BASIC, Item Number: DYNJ904052G, Case UDI/GTIN: 40195327220922, Unit UDI/GTIN: 10195327220921, Lot Number: 22KDA580,22KDA234; iiii. NEURO LUMBAR, Item Number: DYNJ904111I, Case UDI/GTIN: 40193489363518, Unit UDI/GTIN: 10193489363517, Lot Number: 22IBO732,22IBN438,22IBA887; jjjj. NCH NEURO, Item Number: DYNJ904797B, Case UDI/GTIN: 40195327037988, Unit UDI/GTIN: 10195327037987, Lot Number: 22IBF188; kkkk. TAVI, Item Number: DYNJ904981C, Case UDI/GTIN: 40193489475136, Unit UDI/GTIN: 10193489475135, Lot Number: 22JBV630,22JBB134; llll. CHN OR NEURO, Item Number: DYNJ907876A, Case UDI/GTIN: 40195327011117, Unit UDI/GTIN: 10195327011116, Lot Number: 22HBR766; mmmm. NEURO PACK-LF, Item Number: DYNJC9302F, Case UDI/GTIN: 40195327032754, Unit UDI/GTIN: 10195327032753, Lot Number: 22JMB483; nnnn. NEURO-CRANI-LF, Item Number: DYNJS1001A, Case UDI/GTIN: 40080196665373, Unit UDI/GTIN: 10080196665372, Lot Number: 22IBS931,22HBX420
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| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
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| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.