medical MODERATE Updated 2025-02-12

Ethicon, LLC recalls PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 89

See all recalls from Ethicon, LLC →

Recalled Product

PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF/UDI-DI-GTIN/Lot(expiration): EH7585H/10705031097254/103DQR(8/31/2029); 8706H/10705031019430/103E22(8/31/2029), 103EMJ(8/31/2029); 8833H/10705031021037/103HC4(8/31/2029); 8963H/10705031091931/103E8Z(8/31/2029); 8935H/10705031022089/103HBP(8/31/2029)

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for PROLENE Polypropylene Suture, REF: →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Steris Corporation recalls RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Nu

2026-10-21 · If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.

Neuronetics, Inc. recalls NeuroStar Advanced Therapy System. Contains the NeuroStar HP

2026-10-21 · Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

Medline Industries, LP recalls Medline surgical convenience kits labeled as: 1) EAR, Med

2026-10-21 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Boston Scientific Corporation recalls NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number

2026-10-21 · Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.