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Browse Device Recalls

278 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 278 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 278 FDA device recalls.

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DateProductReasonClassFirm
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 30, 2013 High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessor... During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigati... Class II Smith & Nephew, Inc., Endoscopy Div.
Apr 4, 2013 Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic... Driver does not meet specification, oversized. Driver may not be able to be fully inserted into t... Class II Smith & Nephew, Inc., Endoscopy Div.
Apr 4, 2013 Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of or... Driver does not meet specification, oversized. Driver may not be able to be fully inserted into t... Class II Smith & Nephew, Inc., Endoscopy Div.
Mar 6, 2013 TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF ... One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold... Class II Smith & Nephew Inc
Feb 7, 2013 INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAP... 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm scre... Class II Smith & Nephew Inc
Feb 7, 2013 INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAP... 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm scre... Class II Smith & Nephew Inc
Aug 22, 2012 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL ... Modular necks were manufactured out of specification by a vendor; the taper provide is undersized. Class II Smith & Nephew Inc
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.