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: PSN397V (Henry Schein Item No. 600-0331); Product Description: Sterile, synthetic, absorbable, braided 5-0 undyed PGA surgical suture, 27-inch length, with C-6 3/8-circle 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/9d22f6f7-8051-4754-93e6-d690427f6924