Henry Shein Sterile Gloves Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Henry Shein sterile gloves due to pinhole leaks in outer packaging that may compromise sterility. The recall affects approximately 21,755 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile medical device with potential sterility breaches in packaging. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Henry Shein GLOVES in sizes 6.5 through 9.0 manufactured by Stradis Healthcare are subject to recall. The products are sold in 25-pair boxes packaged within 10-pack cases.
The recall is due to the potential for pinhole leaks in the outer bag near the seal. These leaks may result in a breach of the product's sterility, potentially compromising the safety and effectiveness of the gloves.
Approximately 21,755 units were distributed nationwide across Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington. Multiple lot numbers have been identified and are listed in the official recall notice.
Consumers and healthcare facilities should immediately stop using the recalled products. Contact the manufacturer, Stradis Healthcare, or the FDA with any questions regarding specific lot numbers or return procedures.
The recalled product
- 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;
- Manufacturer
- Stradis Healthcare
- Category
- Medical Device — Sterile Gloves
- Hazard
- sterility-breach
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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