Browse Device Recalls

37 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 37 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 37 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jun 2, 2014	SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Co...	Sterility of device is compromised due to breach in sterile barrier	Class II	Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014	SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 722038...	Sterility of device is compromised due to breach in sterile barrier	Class II	Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014	SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, f...	Sterility of device is compromised due to breach in sterile barrier	Class II	Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014	SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 722...	Sterility of device is compromised due to breach in sterile barrier	Class II	Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014	SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fast...	Sterility of device is compromised due to breach in sterile barrier	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black;...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part ...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (b...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (bl...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Par...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 ...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue;...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 ...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 7220077...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: ...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 ...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biod...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 7220077...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / ...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black;...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Num...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; P...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part ...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; P...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Par...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (bl...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Par...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Nu...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Numbe...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013	OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Par...	Pinholes detected in a small number of primary pouches that may constitute a breach of the steril...	Class II	Smith & Nephew, Inc. Endoscopy Division
Jul 14, 2012	Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECU...	Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months ...	Class II	Smith & Nephew, Inc. Endoscopy Division
Jul 14, 2012	Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Nu...	Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months f...	Class II	Smith & Nephew, Inc. Endoscopy Division
Jul 3, 2012	Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID s...	Distal part of the anchor may break on insertion into bone during surgery	Class II	Smith & Nephew, Inc. Endoscopy Division
Jul 3, 2012	Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-bl...	Distal part of the anchor may break on insertion into bone during surgery	Class II	Smith & Nephew, Inc. Endoscopy Division
Jul 3, 2012	Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBR...	Distal part of the anchor may break on insertion into bone during surgery	Class II	Smith & Nephew, Inc. Endoscopy Division
Jul 3, 2012	Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, C...	Distal part of the anchor may break on insertion into bone during surgery	Class II	Smith & Nephew, Inc. Endoscopy Division

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.