Henry Schein Inc.: Suture, Absorbable, Synthetic, Polyglycolic Acid
- Recalling firm
- Henry Schein Inc.
- Product
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN421V (HSI Item No. 600-6870); Product Description: Sterile, synthetic, absorbable, braided 5-0 undyed polyglycolic acid (PGA) surgical suture, 27-inch length, with C-6 3/8-circle surgical needle. Component: N/A;
- Reason
- Products lack 510(k) clearance.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-17
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/64015791-7d16-4030-bdf4-78b69f7b55c0