Browse Device Recalls

395 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 395 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 395 FDA device recalls.

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DateProductReasonClassFirm
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 ... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 24, 2020 LN 3R70-01; software version 2.6.2 and earlier. The software is used with th... Abbott has identified potential performance issues for the Alinity ci -series Software version 2.... Class II Abbott Gmbh & Co. KG
Jan 15, 2020 i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 -... The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status... Class II Abbott Point Of Care Inc.
Jan 15, 2020 i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Pr... The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status... Class II Abbott Point Of Care Inc.
Jan 14, 2020 i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Pro... Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient ... Class II Abbott Point Of Care Inc.
Dec 9, 2019 Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 40... Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths ins... Class II Abbott Medical
Dec 9, 2019 Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of ... Class II Abbott Medical
Nov 14, 2019 FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 000938... Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... Class II Abbott Diabetes Care, Inc.
Nov 14, 2019 Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... Class II Abbott Diabetes Care, Inc.
Nov 14, 2019 Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023,... Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... Class II Abbott Diabetes Care, Inc.
Nov 11, 2019 CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF... A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm... Class II Abbott Medical
Nov 7, 2019 ARCHITECT HAVAB-G Calibrator, REF 6L27-01 Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Rel... Class II Abbott Gmbh & Co. KG
Oct 23, 2019 Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnos... Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed int... Class II Abbott GmBH & Co. KG
Oct 16, 2019 i-STAT cTnI cartridge i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. T... Class II Abbott Point Of Care Inc.
Oct 14, 2019 Radiofrequency Grounding Pad, REF RF-DGP-L Affected lots were manufactured with the protective release liner in an incorrect orientation. W... Class II Abbott Medical
Sep 16, 2019 Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The develop... Class II Abbott Gmbh & Co. KG
Sep 16, 2019 Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The develop... Class II Abbott Gmbh & Co. KG
Sep 16, 2019 Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The develop... Class II Abbott Gmbh & Co. KG
Aug 9, 2019 Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05... The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1... Class II Randox Laboratories Ltd.
Jun 10, 2019 Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usa... Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci seri... Class II Abbott Gmbh & Co. KG
May 24, 2019 ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for... Presence of a time dependent, stability drift in patient and control results returned from ARCHIT... Class III Abbott Laboratories
May 24, 2019 ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators ar... Presence of a time dependent, stability drift in patient and control results returned from ARCHIT... Class III Abbott Laboratories
May 22, 2019 "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR... Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The ma... Class II Abbott Laboratories
May 21, 2019 The Alinity ci-series System Control Modules which are configured with Alinit... All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrate... Class II Abbott Gmbh & Co. KG
May 9, 2019 Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald i... The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner an... Class II Abbott Laboratories
May 1, 2019 Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601... Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunc... Class II Abbott Vascular
May 1, 2019 ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry Sy... Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result ... Class II Abbott Laboratories, Inc
Apr 15, 2019 Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity... Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designe... Class II Abbott Gmbh & Co. KG
Apr 9, 2019 ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calib... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Cali... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators ... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assaye... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHIT... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assaye... Devices were delivered without the required dry ice. Class III Abbott Laboratories

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.