Reported Jan 18, 2023 · Ongoing
Henry Shein GLOVES, packaged in the following sizes and descriptions
Stradis Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stradis Healthcare · 3600 Burwood Dr · Waukegan, IL · 60085-8399
Is this the product you have?
Henry Shein GLOVES, packaged in the following sizes and descriptions
6 of 6 products
| # | Product as published |
|---|---|
| 1 | Glove 6.5 Pack, 25 Pairs, 10 packs per case |
| 2 | Glove 7.0 Pack, 25 Pairs, 10 packs per case |
| 3 | Glove 7.5 Pack, 25 Pairs, 10 packs per case |
| 4 | Glove 8.0 Pack, 25 Pairs, 10 packs per case |
| 5 | Glove 8.5 Pack, 25 Pairs, 10 packs per case |
| 6 | Glove 9.0 Pack, 25 Pairs, 10 packs per case |
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Assembly Number 570-1159, UDI-DI: H65857011591, Lot Numbers: 221668682, 222501598, 222308841, 222521158, 222238329, 222276824, 221053079, 221872664 2 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 3 Assembly Number 570-1161, UDI-DI: H65857011611, Lot Numbers: 220692475, 222308200, 220251830, 220954105, 220962657, 222248185, 220250698, 222298349, 220251993, 222308198, 222298840, 222521804, 220963077, 220986550, 220141428 4 Assembly Number 570-1162, UDI-DI: H65857011621, Lot Numbers: 221196021, 220462656, 221056018, 221056532, 222308350, 221176016, 221054106, 221056019, 222308552, 222501299, 222501300, 222521301, 220973076, 220896020, 221026017, 213631427 5 Assembly Number 570-1164, UDI-DI: H65857011641, Lot Numbers: 222016037, 222358186, 222430336, 221946035, 222439014, 222430367, 222630366, 222902499, 220252640, 222496579, 221053074, 222350340, 222016033, 222016036, 222146031, 222358129, 222358550, 222496823, 222691515, 220462661, 222692162, 222016034, 222509320, 222692160, 221956029, 220452523, 222016032, 222499000 6 Assembly Number 570-1163, UDI-DI: H65857011631, Lot Numbers: 222290711, 221796024, 221796026, 221796027, 222497161, 222509729, 222510199, 221193075, 222458997, 221024107, 221796025, 222509511, 221796023, 221796022 - Amount recalled
- 21,755 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
Why it was recalled
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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