Henry Shein GLOVES — Class II medical device recall Z-0934-2023
Ongoing recall by Stradis Healthcare, reported 2023-01-18, distributed nationwide. Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility
| Recall number | Z-0934-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stradis Healthcare, Waukegan, IL, United States |
| Recall initiated | 2022-12-15 |
| Classified | 2023-01-11 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Quantity | 21,755 units |
| Reason classes | sterility, packaging |
| Lot numbers | 213631427, 220141428, 220141429, 220250698, 220251830, 220251993, 220252640, 220452523, 220452660, 220462656, 220462661, 220692475, 220762521, 220896020, 220954105, 220962657, 220963077, 220973076, 220982614, 220984273, 220986550, 221013080, 221024107, 221026017, 221053074, 221053079, 221054106, 221055116, 221056018, 221056019, 221056532, 221176016, 221193075, 221196021, 221668682, 221796022, 221796023, 221796024, 221796025, 221796026 and 68 more |
Product
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove 9.0 Pack, 25 Pairs, 10 packs per case;
Reason for recall
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
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-0934-2023. 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.