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Browse Device Recalls

3,179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,179 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 3,179 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 8, 2013 SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mes... Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and... Class II Allergen Medical
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capac... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removab... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capaci... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capac... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double ... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removabl... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capaci... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 14, 2012 Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm... Some of the individual extension set packages were improperly sealed, compromising the sterility ... Class II Baxter Healthcare Corp.
Nov 21, 2012 Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tra... Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the se... Class II Merit Medical Systems, Inc.
Nov 19, 2012 Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioA... Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that c... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Nov 5, 2012 MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardia... The seal between the white polyethylene and the clear plastic may be missing on the Hand Controll... Class II Medrad Inc
Oct 29, 2012 Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Devi... Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achiev... Class II Cordis Corporation
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Par... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part#... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, P... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Par... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 4, 2012 PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routi... Damage to the packaging may have compromised the sterility of the device. Class II Ethicon Endo-Surgery Inc
Sep 25, 2012 Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Telefl... Product is being recalled due to the possibility that the tray may contain pinholes, compromising... Class II Teleflex Medical
Aug 29, 2012 Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Rem... Sterility of the product may be compromised. Class II Remington Medical Inc.
Aug 9, 2012 Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable... There is potential for the sterility of the product to be compromised. Class II Intuitive Surgical, Inc.
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 2, 2012 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into... On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it ... Class III Steris Corporation
Jun 26, 2012 BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethyle... BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440... Class II Bridgepoint Medical
Jun 13, 2012 seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product ... Sterility of product may be compromised due to packaging defect Class II Genzyme Corporation
Jun 13, 2012 seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Pro... Sterility of product may be compromised due to packaging defect Class II Genzyme Corporation
Jun 11, 2012 Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold un... This letter is to notify you that several of our sterile screw products are being voluntarily rec... Class II Tedan Surgical Innovations Llc

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.