Sterile Procedural Trays — Class II medical device recall Z-1088-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-02-15, distributed nationwide. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the st
| Recall number | Z-1088-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-11-17 |
| Classified | 2023-02-06 |
| Reported by FDA | 2023-02-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, JP, MX, PA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10080196665372, 10080196777952, 10193489224580, 10193489225228, 10193489225235, 10193489231205, 10193489232066, 10193489301342, 10193489308082, 10193489310474, 10193489357530, 10193489363517, 10193489426984, 10193489444148, 10193489444810, 10193489475135, 10193489506884, 10193489565027, 10193489615012, 10193489675672, 10193489676365, 10193489710359, 10193489733600, 10193489803693, 10193489815450 and 159 more |
| Lot numbers | 22GBG964, 22GMB860, 22HBM006, 22HBM512, 22HBN525, 22HBP196, 22HBP277, 22HBP962, 22HBR766, 22HBV048, 22HBV288, 22HBV379, 22HBV694, 22HBW509, 22HBX254, 22HBX309, 22HBX420, 22HBX977, 22HBX978, 22HBX979, 22HBX980, 22HBY116, 22HBY346, 22HBZ336, 22HDC097, 22HLB020, 22HMB824, 22HMB884, 22HMC380, 22HMC512, 22HMD049, 22HMD080, 22HMD278, 22HMD361, 22HMD563, 22HMD792, 22HMD933, 22HME671, 22HMF079, 22HMI113 and 113 more |
| Model numbers | CDS983098D, CDS983186J, CDS985289, CDS985548N, DYNJ0038440B, DYNJ0190156F, DYNJ0367094L, DYNJ0374024J, DYNJ04596K, DYNJ04671Q, DYNJ0781823K, DYNJ07952J, DYNJ14032, DYNJ14077I, DYNJ16473K, DYNJ19847M, DYNJ21243M, DYNJ21244N, DYNJ21925S, DYNJ25097F, DYNJ30477K, DYNJ35349C, DYNJ35480F, DYNJ36594F, DYNJ37741B and 67 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1088-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.