Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter Recalled by Surgical Instrument Service And Savings, Inc. Due to The seal which maintains a sterile barrier for...

Date: May 3, 2013
Company: Surgical Instrument Service And Savings, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Surgical Instrument Service And Savings, Inc. directly.

Affected Products

-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W. REF PXW35 Lot 122309 and Lot 123263. -Proximate Linear Cutter, w/o Staples 75mm. REF TLC75 Lot 122490 -Ethicon Proximate Plus MD, Skin Stapler Regular. REF PMR35 Lot 122753. -Proximate Plus, Rotating Head, Skin Stapler (White) Wide. REF PRW35 Lot 122406. - Ethicon PROXIMATE PLUS, Skin Stapler, Pistol Grip, Fixed Head, Multi-Directional Release, (Grey) Regular. REF PXR35 Lot 122675 and Lot 123263. -TX Reloadable Linear Stapler 3.5mm Leg, w/o Staples 60mm. Ref. TX60B Lot 122490 Manual surgical instrument for general use

Quantity: 13

Why Was This Recalled?

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Surgical Instrument Service And Savings, Inc.

Surgical Instrument Service And Savings, Inc. has 22 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report