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Browse Device Recalls

1,694 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,694 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 1,694 FDA device recalls.

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DateProductReasonClassFirm
Apr 13, 2016 Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor... Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used ... Class I Medtronic
Apr 8, 2016 Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for u... Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecti... Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Apr 1, 2016 Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) I... Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm Class II Medtronic
Apr 1, 2016 Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) ... Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm Class II Medtronic
Mar 31, 2016 Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (... A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLin... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Mar 29, 2016 ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, S... Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.... Class II ev3, Inc.
Mar 21, 2016 Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom conven... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 21, 2016 General Surgery Pack, part number 006880-3. This is a custom convenience sur... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, Inc.
Mar 21, 2016 Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenien... These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... Class II Windstone Medical Packaging, 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 23, 2016 Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneo... Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" P... Class II Covidien Medical Products (Shanghai) Manufactur...
Feb 23, 2016 Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous E... Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ IC... Class II Medtronic Inc.
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.
Feb 19, 2016 CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospec... Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink i... Class II Medtronic MiniMed Inc.
Feb 9, 2016 Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Eth... Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intra... Class II Medtronic Neuromodulation
Feb 4, 2016 Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascu... Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tub... Class III Medtronic Perfusion Systems
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.
Jan 15, 2016 Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Int... Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certai... Class II Covidien LP (formerly Nellcor Puritan Bennett I...
Jan 11, 2016 Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal co... Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between... Class II Medtronic Neuromodulation
Dec 2, 2015 Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND ... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Dec 2, 2015 Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Pr... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Dec 2, 2015 Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHOR... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Dec 2, 2015 Best Practice Kits containing certain production lots of Endo GIA Ultra Unive... Staplers fail to fire or partially fire and reports of the instrument articulating lever disengag... Class II Medtronic
Nov 9, 2015 Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generat... Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term batte... Class II Medtronic Inc.
Oct 28, 2015 Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Ste... This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactu... Class II Medtronic Perfusion Systems
Oct 23, 2015 Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 A... Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter hav... Class II Medtronic Vascular, Inc.
Oct 21, 2015 Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used... The wire pass hole is not present on the tools. Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Sep 29, 2015 Medtronic Achieve Cables, model 990066. The sterile, single use only Electri... 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. Class II Medtronic Inc.
Sep 25, 2015 MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Sep 25, 2015 MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 T... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Sep 15, 2015 Medtronic Medical Device Identification Card for SureScan pacemaker patients.... Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they ha... Class II Medtronic Inc. Cardiac Rhythm Disease Management
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.
Sep 1, 2015 Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performin... An issue with a USB memory component contained within a subset of CryoConsoles can result in exte... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Aug 27, 2015 Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the ... Class II Arrow International Inc
Aug 18, 2015 MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist ... Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... Class II Medtronic Perfusion Systems
Aug 18, 2015 MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators... Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... Class II Medtronic Perfusion Systems
Jul 24, 2015 Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to... EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. Class II Medtronic Perfusion Systems
Jul 22, 2015 Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or p... Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System becaus... Class II Medtronic MiniMed 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.
Jul 15, 2015 EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-... Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. Class I Medtronic Cardiovascular Surgery-the Heart Valv...
Jun 19, 2015 MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), ... Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain ... Class II Medtronic MiniMed Inc.
Jun 12, 2015 Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and D... Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports ... Class II Medtronic Perfusion Systems
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 29, 2015 Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glov... Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufa... Class II Centurion Medical Products Corporation
Apr 27, 2015 Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ... Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or... Class II DeRoyal Industries Inc
Apr 22, 2015 Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS332... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, 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.