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Browse Device Recalls

112 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 112 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 112 FDA device recalls.

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DateProductReasonClassFirm
Jun 29, 2017 Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When u... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on ... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When ... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Shor... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, R... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit incl... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 7, 2017 Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9... Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (... Class II Medtronic Navigation, Inc.
May 10, 2017 Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Software issue related to the StealthStation S7 system and the Synergy Spine application Version ... Class II Medtronic Navigation, Inc.
Dec 12, 2016 AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG... Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Pr... Class II Medtronic Navigation, Inc.
Sep 22, 2016 Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number:... O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigate... Class II Medtronic Navigation, Inc.-Littleton
Sep 1, 2016 Visualase Body Accessory Kit PN 020-3000. The individual components within th... Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Sty... Class II Medtronic Navigation, Inc.
Sep 1, 2016 Visualase Visualization Stylets PN 020-2301. The individual components within... Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Sty... Class II Medtronic Navigation, Inc.
Jul 18, 2016 MACH Cranial Treon. The software application is sent in CD format with an IFU... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 MACH AxiEM Cranial Treon. The software application is sent in CD format with ... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 Synergy Spine. The software application is sent in CD format with an IFU, wra... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 Fusion ENT Application. The software application is sent in CD format with an... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 Synergy Cranial S7. The software application is sent in CD format with an IFU... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 FrameLink. The software application is sent in CD format with an IFU, wrapped... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 S7 MACH FrameLink. The software application is sent in CD format with an IFU,... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
May 9, 2016 Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists ... Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during proc... Class II Medtronic Navigation, Inc.
Mar 17, 2016 Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027,... It has been discovered that replacement x-ray generator and system motion batteries could become ... Class II Medtronic Navigation, Inc.-Littleton
Mar 17, 2016 Medtronic Navigation O-arm 02 surgical x-ray imaging system Review of on-system electronic product labeling and Instr uctions for Use in response to an inter... Class II Medtronic Navigation, Inc.-Littleton
Feb 22, 2016 BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile i... Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed ... Class II Medtronic Navigation, Inc.
Jan 29, 2016 Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2... Screws holding the detector panel in as a result the detector panel could make contact with othe... Class II Medtronic Navigation, Inc.
Sep 14, 2015 P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024... Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking d... Class II Medtronic Navigation, Inc.
Sep 14, 2015 P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVE... Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking d... Class II Medtronic Navigation, Inc.
Jul 17, 2015 Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Nee... The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing ... Class II Medtronic Navigation, Inc.
Jul 17, 2015 Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee... The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing ... Class II Medtronic Navigation, Inc.
May 26, 2015 Medtronic Navigated Cannulated Taps Individual cannulated taps are package... Medtronic Navigation is initiating a field correction due to the potential for injury which could... Class II Medtronic Navigation, Inc.
May 5, 2015 Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Pa... Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip. Class II Medtronic Navigation, Inc.
Apr 24, 2014 DISP 9730951 STRL SPHERE, 5PK INSERT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PACK 9731975 TUMOR RESECTION AXIEM CR Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BAG 9732315 MOUSE STERILE 15 PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PIN, 9733235, 100MM, STERILE, PERC REF Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PATIENT TRACKER 9733534XOM ENT 1PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BIOPSY NEEDLE KIT, 9733068, PASSIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 INST 9731132 KIT CR REF FRAME DRIVER 5PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RESECTION KIT 9733608 SKULL MOUNT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PIN, 9733236, 150MM, STERILE, PERC REF Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TRAJ GUIDE KIT, 9733066, BIOPSY, INT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 DISP 9730950 STRL SPHERE, 1 PK INSERT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 INSTRUMENT TRACKER 9733533XOM ENT 1PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SHUNT KIT 9733605 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RESECTION KIT 9733607 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SPHERES 8801075 5/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BIT 9733516 2.9mm DRILL STERILE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TRAJ GUIDE KIT, 9733065, BIOPSY, EXT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SPHERES 8801071 1/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, 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.