Browse Device Recalls
2,049 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,049 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 2,049 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 13, 2020 | Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental u... | Restorations crack during the sintering process. | Class II | Ivoclar Vivadent AG |
| Apr 13, 2020 | Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental ... | Restorations crack during the sintering process. | Class II | Ivoclar Vivadent AG |
| Apr 13, 2020 | Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental... | Restorations crack during the sintering process. | Class II | Ivoclar Vivadent AG |
| Apr 13, 2020 | Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental... | Restorations crack during the sintering process. | Class II | Ivoclar Vivadent AG |
| Apr 9, 2020 | BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... | The products have the potential to leak between the connection of the male luer and the yellow st... | Class II | BD SWITZERLAND SARL |
| Apr 9, 2020 | The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051... | A software issue that may affect the analyzer's result accuracy. | Class II | The Binding Site Group, Ltd. |
| Apr 9, 2020 | BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... | The products have the potential to leak between the connection of the male luer and the yellow st... | Class II | BD SWITZERLAND SARL |
| Apr 9, 2020 | BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... | The products have the potential to leak between the connection of the male luer and the yellow st... | Class II | BD SWITZERLAND SARL |
| Apr 7, 2020 | Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-2... | The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... | Class II | Inpeco S.A. |
| Apr 7, 2020 | Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, F... | The identified problem is an erroneous association between the carrier and the sample tube caused... | Class II | Inpeco S.A. |
| Apr 7, 2020 | Accelerator a3600 Automation System used with the following Modules: High Vol... | The sensors which activate the safety switches may be affected by delayed activation. In 1% of t... | Class II | Inpeco S.A. |
| Apr 7, 2020 | FlexLab Automation System used with the following Modules: High Volume Storag... | The sensors which activate the safety switches may be affected by delayed activation. In 1% of t... | Class II | Inpeco S.A. |
| Apr 7, 2020 | Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Pa... | When analyzer sample carousel lid remains open or manual process is too long, Module timeout expi... | Class II | Inpeco S.A. |
| Apr 7, 2020 | FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The... | Potential for discrepant patient results due to a potential for the primary sample tube to be dil... | Class II | Inpeco S.A. |
| Apr 7, 2020 | Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Pro... | In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generat... | Class II | Inpeco S.A. |
| Apr 7, 2020 | FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00,... | The identified problem is an erroneous association between the carrier and the sample tube caused... | Class II | Inpeco S.A. |
| Apr 7, 2020 | Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA... | The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... | Class II | Inpeco S.A. |
| Apr 7, 2020 | Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FL... | In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generat... | Class II | Inpeco S.A. |
| Apr 7, 2020 | Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N F... | The identified problem is an erroneous association between the carrier and the sample tube caused... | Class II | Inpeco S.A. |
| Apr 7, 2020 | Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers... | When analyzer sample carousel lid remains open or manual process is too long, Module timeout expi... | Class II | Inpeco S.A. |
| Apr 7, 2020 | Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA ... | The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage t... | Class II | Inpeco S.A. |
| Apr 6, 2020 | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type numbe... | Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calcula... | Class II | Agfa N.V. |
| Apr 3, 2020 | VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 -... | While transferring blood the needle may dislodged and remain in the tube stopper which may cause ... | Class II | C.A. Greiner & Sohne Gesellschaftmbh |
| Apr 3, 2020 | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medulla... | The lot number on the pediatric orthopedic implant driver instrument handle does not match the lo... | Class III | Pega Medical Inc. |
| Mar 26, 2020 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550, ... | In affected software version, of Positron emission tomography and computed tomography system, the... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Mar 23, 2020 | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 11165... | The analyzer system may have an electrostatic discharge and sparking of the power supply provided... | Class II | Abbott Diagnostics Technologies AS |
| Mar 23, 2020 | Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the tr... | It was identified that there is a potential for the Stim Interconnecting high Voltage Cable locat... | Class II | The Magstim Company Limited |
| Mar 23, 2020 | Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated ... | It was identified that there is a potential for the Stim Interconnecting high Voltage Cable locat... | Class II | The Magstim Company Limited |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single u... | RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was la... | Class II | Rayner Intraocular Lenses Limited |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... | Class II | Radiometer Medical ApS |
| Mar 17, 2020 | safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... | Class II | Radiometer Medical ApS |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 17, 2020 | safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... | Class II | Radiometer Medical ApS |
| Mar 17, 2020 | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD ... | Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... | Class II | Degania Medical Devices Pvt. Ltd. |
| Mar 10, 2020 | ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of wh... | Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ... | Class II | Radiometer Medical ApS |
| Mar 9, 2020 | ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. | An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading t... | Class II | Abbott Gmbh & Co. KG |
| Mar 6, 2020 | ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 | Through internal investigation is has been determined that an incorrect component was used within... | Class II | Radiometer Medical ApS |
| Mar 6, 2020 | Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Ra... | The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use... | Class II | R82 A/S |
| Mar 5, 2020 | natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph | The OBM system functional test (impedance and noise) was not carried out on the affected items pr... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Mar 4, 2020 | RayStation standalone software treatment planning system, Model Numbers 4.0, ... | Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtu... | Class II | RAYSEARCH LABORATORIES AB |
| Mar 2, 2020 | Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-defic... | Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the ... | Class II | CSL Behring GmbH |
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.