Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 25, 2018 | Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMa... | Calibration setting was incorrectly entered during manufacturing causing the optical coherence to... | Class II | Carl Zeiss Meditec AG |
| Jun 25, 2018 | POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA ... | Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experien... | Class II | Bard Peripheral Vascular Inc |
| Jun 25, 2018 | Leica M530 OHX Microscope System Supplied with 100 - 120 Vac. | Recall is due to a design weakness of the power insert module. | Class II | Leica Microsystems, Inc. |
| Jun 22, 2018 | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part ... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Numb... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 1... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10... | Potential hardware issue which may cause thermal effects and possible damage to system parts. | Class II | Siemens Medical Solutions USA, Inc |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part ... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Produ... | Potential hardware issue which may cause thermal effects and possible damage to system parts. | Class II | Siemens Medical Solutions USA, Inc |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part N... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCRE... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 1... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCRE... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Num... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Numb... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial B... | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain th... | Class II | Smiths Medical ASD Inc. |
| Jun 22, 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part N... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-00... | The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was u... | Class II | Zimmer Biomet, Inc. |
| Jun 22, 2018 | AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: ... | Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for u... | Class III | Clarity Diagnostics Llc |
| Jun 22, 2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING ... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Nu... | After a three year term, there is a potential for the external packaging (sterile barrier) to bec... | Class II | Stryker Leibinger GmbH & Co. KG |
| Jun 22, 2018 | Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial B... | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain th... | Class II | Smiths Medical ASD Inc. |
| Jun 21, 2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KOD... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Pr... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Pro... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The imp... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Del... | Expired intraocular lenses were distributed. | Class II | Johnson & Johnson Surgical Vision Inc |
| Jun 21, 2018 | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Pro... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Pr... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Pro... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The imp... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
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.