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Browse Device Recalls

22 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 22 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 22 FDA device recalls.

Clear
DateProductReasonClassFirm
May 3, 2013 - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Dril... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 12244... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Nee... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlle... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0m... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manua... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Hea... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink)... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples ... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-1... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen,... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308,... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DV... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. ... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm R... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot ... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.