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Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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DateProductReasonClassFirm
Oct 6, 2016 14cm QD Angle Attachment Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Keyless Driver Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 SCC Soft Computer Softbank II software Product Usage: Supports single and... Software error. Potential for incorrect results Class II Soft Computer Consultants, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Ca... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed ... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 107587500062... The device defect is a positive bias of up to 20% relative to the currently marketed Roche device... Class II ORTHO-CLINICAL DIAGNOSTICS
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is des... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The... The Drager Pendula spring arm device has a set of screws located on the spring arm that were not... Class II Steris Corporation
Oct 5, 2016 Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Car... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Cath... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is desig... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is desig... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designe... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardio... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed ... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiolo... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. ... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Cata... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiolo... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardio... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test) Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias wit... Class II Siemens Healthcare Diagnostics, Inc
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is de... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . ... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 Accessory Adapter Part number 600525A0 Product Usage: designed for the mo... Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 ... Class II Maquet Medical Systems USA
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is des... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box),... Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instea... Class II C.R. Bard, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatal... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test) Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias wit... Class II Siemens Healthcare Diagnostics, Inc
Oct 5, 2016 Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Us... Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set sc... Class II Alphatec Spine, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Cat... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is design... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Alligator Retrieval Device The device is intended for use in the peripheral ... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 Pipeline Embolization Device (Pipeline Classic) The device is indicated for ... Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PT... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Oct 5, 2016 OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is desi... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Ca... Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... Class II Oscor, Inc.
Oct 5, 2016 Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Card... Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... Class II Stryker Neurovascular
Oct 5, 2016 da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software;... Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can resu... Class II Intuitive Surgical, 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.