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PERMA-HAND recallZ-0153-2027 · Ethicon, LLC · initiated Sep 8, 2026

Open, Classified All recalls posted in October 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process control

What the company is doing

On 9/8/2026, recall notices were mailed to customers who were asked to do the following: 1) Quarantine affected products. Maintain a copy of this notice with the quarantined product and keep a copy for your records. 2) Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return and forward them this recall notice. 3) Complete and return the Business Reply Form via email to [email protected] 4) Return affected product using the shipping label provided. In addition distributors were told the following: Based on your reported sales data, Ethicon will send notices directly to customers about the product subject to this recall. This notice will include instructions on returning the product for credit reimbursement. Distribute this notice within your organization and to any non-customer organization that received affected product from your facility. If you have additional questions regarding this communication or want to report any product complaints, please contact the firm's Resource Department at 1-877-384-4266.

Recall details

Recall number
Z-0153-2027
Recall class
Not yet classified by the FDA
Status
Open, Classified
Initiated by the company
Sep 8, 2026
Posted by the FDA
Oct 14, 2026
Recalling firm
Ethicon, LLC
Quantity
1764
Product code
GAQ
FDA submissions
K946173
Distribution
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.

Product description

PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H

Code information (models, lots, serial numbers)

UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

456 devices cleared under K946173 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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