Sterile Procedural Trays — Class II medical device recall Z-1093-2023
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-1093-2023 |
|---|---|
| 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 | 10193489313765, 10193489413113, 10193489467505, 10193489651263, 10193489729993, 10193489850604, 10193489899924, 10193489926729, 10193489944228, 10193489951608, 10193489976472, 10193489979572, 10193489996944, 10193489998566, 10195327008697, 10195327024369, 10195327025953, 10195327030315, 10195327038472, 10195327143985, 10195327148195, 10195327164607, 10195327171506, 10195327199562, 10195327224769 and 41 more |
| Lot numbers | 22HBN532, 22HBU206, 22HBU577, 22HBU964, 22HBW646, 22IBA054, 22IBA619, 22IBB420, 22IBC141, 22IBD109, 22IBD796, 22IBE548, 22IBJ500, 22IBK842, 22IBP589, 22IBQ666, 22IDA203, 22IDA274, 22IDA372, 22IDA825, 22IDC076, 22IMD263, 22JBG106, 22JBK303, 22JBM359, 22JBM626, 22JBM950, 22JBN288, 22JBN433, 22JBN742, 22JBO175, 22JBO188, 22JBO684, 22JBO747, 22JBR451, 22JBU057, 22JBY522, 22JDB955, 22JMD314, 22JME324 and 5 more |
| Model numbers | CDS830215G, CDS980754R, CDS982249I, CDS983207M, CDS983455C, CDS984201T, CDS985547N, DYNJ0161768F, DYNJ0209066N, DYNJ0373807K, DYNJ20485L, DYNJ25971I, DYNJ36731F, DYNJ40409C, DYNJ43887, DYNJ48918J, DYNJ49221C, DYNJ51386B, DYNJ52095I, DYNJ53804, DYNJ63145A, DYNJ80430, DYNJ82634, DYNJ900721C, DYNJ902373I and 8 more |
Product
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-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-1093-2023. 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.