CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
Perma-hand Silk Black Braided Sterile Nonabsorbable recalled by Ethicon
Ethicon is recalling Perma-hand Silk Black Braided Sterile Nonabsorbable Surgical Suture, " TF-5, distributed nationwide in the US. The recall was initiated on 8 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0153-2027
- FDA event ID
- 99754
- Recalling firm
- Ethicon, San Lorenzo, PR
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Sep 2026
- FDA classified
- 14 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 8 Sep 2026 | Recall initiated by company | |
| 14 Oct 2026 | Classified by FDA | +36 days |
| 21 Oct 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Where it was distributed
Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaIdahoIllinoisIndianaLouisianaMassachusettsMaineMinnesotaMissouriNorth CarolinaNebraskaNew HampshireNew YorkOhioOklahomaPennsylvania
Questions about this recall
Why was it recalled?
Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
Which lots are affected?
UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026
Where was it sold?
Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ethicon
All 77| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled | Ethicon | Other | Nationwide |
| Device | CLASS II | Perma-hand Silk Suture recalled by Ethicon | Ethicon | Sterility | Nationwide |
| Device | CLASS II | Ethibond Excel Polyester Suture recalled by Ethicon | Ethicon | Sterility | Nationwide |
| Device | CLASS II | Prolene Polypropylene Suture recalled by Ethicon | Ethicon | Sterility | Nationwide |
| Device | CLASS II | Monocryl" (poliglecaprone Suture recalled by Ethicon | Ethicon | Packaging Defects | 45 states |
Other Surgical Instruments recalls
All 3,902| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline surgical convenience kits labeled as: EAR recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Scout MD recalled by Merit Medical Systems | Merit Medical Systems | Other | 7 states |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |