Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

Clear
DateProductReasonClassFirm
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 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 ST Product Code: GST51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread L... Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly et... Class II Synthes USA HQ, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 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 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 Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also kn... The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Den... Class II Synthes USA HQ, 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 10, 2013 Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidew... The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the meas... Class II Extremity Medical LLC
Jan 9, 2013 Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models... GE Healthcare has recently become aware of an incident which caused a patient injury during an un... Class II GE Healthcare, LLC
Jan 9, 2013 Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the ... Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, par... Class II Envoy Medical Corporation
Jan 8, 2013 Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) label... Neonatal beds and incubator display boards may randomly overwrite stored information and radiant ... Class I GE Healthcare, LLC
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
Jan 7, 2013 Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, sut... Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... Class II Terumo Cardiovascular Systems Corporation
Jan 7, 2013 Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, ... Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... Class II Terumo Cardiovascular Systems Corporation
Jan 7, 2013 Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecon... There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the... Class II Integra LifeSciences Corp.
Jan 7, 2013 Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, sutu... Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... Class II Terumo Cardiovascular Systems Corporation
Jan 7, 2013 Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, ... Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... Class II Terumo Cardiovascular Systems Corporation
Jan 7, 2013 Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ... Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... Class II Terumo Cardiovascular Systems Corporation
Jan 7, 2013 Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, ... Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain... Class II Terumo Cardiovascular Systems Corporation
Jan 4, 2013 LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... Class I DePuy Orthopaedics, Inc.
Jan 4, 2013 LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... Class I DePuy Orthopaedics, Inc.
Jan 4, 2013 The product is labeled in part "***Surgical Laser Technologies, Inc. Montgome... Firm became aware that some products within the specified lot may not have been sealed appropriat... Class II PhotoMedex, Inc.
Jan 4, 2013 LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... Class I DePuy Orthopaedics, Inc.
Jan 4, 2013 LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used... DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the prod... Class I DePuy Orthopaedics, Inc.
Jan 3, 2013 Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indic... Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pu... Class I Animas Corporation
Jan 3, 2013 TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manu... Thru hole at the tip of the screw is undersized. Class II Biomet, Inc.
Jan 2, 2013 The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for ... Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective lab... Class I Lumenis Limited

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.