FDA Device recall Z-0934-2023
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case by Stradis Healthcare, citing potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0934-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-15 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stradis Healthcare |
| Distribution | US |
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
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Identifiers
| code_info | Assembly Number 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220…Assembly Number 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161. a. Assembly Number 570-1159, UDI-DI: H65857011591, Lot Numbers: 221668682, 222501598, 222308841, 222521158, 222238329, 222276824, 221053079, 221872664; b. Assembly Number 570-1160, UDI-DI: H65857011601, Lot Numbers: 222521156, 222429019, 222428991, 220452660, 222439059, 222428995, 221055116, 222288188, 222501154, 222501155, 222521157, 220762521, 222509319, 222769004, 222639005, 220141429, 222508994; c. Assembly Number 570-1161, UDI-DI: H65857011611, Lot Numbers: 220692475, 222308200, 220251830, 220954105, 220962657, 222248185, 220250698, 222298349, 220251993, 222308198, 222298840, 222521804, 220963077, 220986550, 220141428; d. Assembly Number 570-1162, UDI-DI: H65857011621, Lot Numbers: 221196021, 220462656, 221056018, 221056532, 222308350, 221176016, 221054106, 221056019, 222308552, 222501299, 222501300, 222 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0934-2023%22
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