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FDA recall, , Moderate risk

Henry Schein Perma Sharp Surgical Sutures

Perma Sharp Sutures lack 510(k) clearance.

Summary by Recall Canary from the FDA notice

What happened

Henry Schein Inc. of Denver, Pennsylvania, voluntarily recalled Perma Sharp Sutures because the products lack 510(k) clearance. The recall began September 17, 2026, and was added to the FDA's Enforcement Report and classified on November 3, 2026. The sutures include sterile synthetic and natural varieties, such as polypropylene nonabsorbable, PGA absorbable, and silk nonabsorbable surgical sutures, in blue, violet, black, or undyed, with various needles.

The products were distributed nationwide in the U.S. and in Canada, Uganda, and the Cayman Islands. Customers were notified by letter. The recall was initiated voluntarily by the firm.

More unapproved product recalls

What to do

The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Match your product and all the details in one listed combination.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Perma Sharp Sutures

    1. UDI-DI
      • 10889950001896
      Lot code
      • 0624002HF
      • 0625007HF
      • 0625017HF
      • 0625020HF
      • 0625025HF
      • 0625026HF
      Model/Catalog number
      PSN8660P (HSI Item No. 600-7193)
      Generic name
      Polypropylene Nonabsorbable Surgical Suture
    2. UDI-DI
      • 10889950001926
      Lot code
      • 0624001HF
      • 0624004HF
      • 0624010HF
      Model/Catalog number
      PSN8695P (HSI Item No. 600-9795)
      Generic name
      Polypropylene Nonabsorbable Surgical Suture
    3. UDI-DI
      • 10889950001865
      Lot code
      • 0624002HF
      • 0625001HF
      • 0625002HF
      • 0625003HF
      • 0625017HF
      • 0625022HF
      • 0625027HF
      Model/Catalog number
      PSN8384P (HSI Item No. 600-7664)
      Generic name
      Polypropylene Nonabsorbable Surgical Suture
    4. UDI-DI
      • 10889950001285
      Lot code
      • 0924005HF
      • 0924006HF
      • 0924007HF
      • 0925019HF
      • 0925023HF
      • 0925033HF
      • 0925049HF
      • 0925050HF
      • 0925051HF
      • 0925055HF
      Model/Catalog number
      PSN392V (HSI Item No. 600-9613)
      Generic name
      PGA Absorbable Surgical Suture
    5. UDI-DI
      • 10889950001605
      Lot code
      • 0124001HF
      • 0124002HF
      • 0125009HF
      • 0125010HF
      • 0125026HF
      • 0125034HF
      • 0125040HF
      • 0125041HF
      Model/Catalog number
      PSN683S (HSI Item No. 600-6411)
      Generic name
      Silk Nonabsorbable Surgical Suture
    6. UDI-DI
      • 10889950001957
      Lot code
      • 0624014HF
      Model/Catalog number
      PSN8698P (HSI Item No. 600-5659)
      Generic name
      Polypropylene Nonabsorbable Surgical Suture
    7. UDI-DI
      • 10889950001254
      Lot code
      • 0925007HF
      • 0925020HF
      Model/Catalog number
      PSN387V (HSI Item No. 600-9683)
      Generic name
      PGA Absorbable Surgical Suture
    8. UDI-DI
      • 10889950001315
      Lot code
      • 0924017HF
      Model/Catalog number
      PSN421V (HSI Item No. 600-6870)
      Generic name
      PGA Absorbable Surgical Suture
    9. UDI-DI
      • 10889950001933
      Lot code
      • 0624001HF
      Model/Catalog number
      PSN8696P (Henry Schein Item No. 600-0115)
      Generic name
      Polypropylene Suture
    10. UDI-DI
      • 10889950001506
      Lot code
      • 0125008HF
      • 0125016HF
      • 0125028HF
      • 0125031HF
      Model/Catalog number
      PSN632S (HSI Item No. 600-3506)
      Generic name
      Silk Nonabsorbable Surgical Suture
    11. UDI-DI
      • 10889950001261
      Lot code
      • 0924004HF
      • 0925023HF
      Model/Catalog number
      PSN388V (HSI Item No. 600-8803)
      Generic name
      PGA Absorbable Surgical Suture
    12. UDI-DI
      • 10889950001308
      Lot code
      • 0925013HF
      Model/Catalog number
      PSN397V (Henry Schein Item No. 600-0331)
      Generic name
      PGA Absorbable Surgical Suture
    13. UDI-DI
      • 10889950001810
      Lot code
      • 0125005HF
      • 0125028HF
      Model/Catalog number
      PSN7772S (HSI Item No. 600-3090)
      Generic name
      Silk Nonabsorbable Surgical Suture

Recall details

Posted by FDA
Recall began
Status
Open
Weekly archive
Listed the week of Nov 2, 2026
Sold in

U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.

Recalled by
Henry Schein Inc.Denver, Pennsylvania
Hazard
Unapproved product
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

FDA event number
100016
Recall numbers
Z-0334-2027 to Z-0346-2027
Recall type
Voluntary: Firm initiated
How the company first told customers
Letter

All recalls from Henry Schein Inc.

Timeline

FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.

  1. Henry Schein began the recall

  2. FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)

  3. Added to Recall Canary

Other unapproved product recalls

See all: Other unapproved product recalls

Summary by Recall Canary, written with AI · summary updated Nov 4, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)