Browse Device Recalls
1,040 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,040 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 1,040 FDA device recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Use... | Device was shipped without a Unique Device Identification (UDI) label and a separate label identi... | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System | 905 nm laser diodes may be below rated power output. | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System | Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-... | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 | Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and I... | Class III | Theralase Inc. |
| Sep 23, 2019 | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. | Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and sh... | Class III | Randox Laboratories, Limited |
| Sep 18, 2019 | Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples. | The metal cannula of the device either broke and the broken piece left in the blood specimen tube... | Class III | Biomedical Polymers, Inc. |
| Sep 18, 2019 | Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood... | The metal cannula of the device either broke and the broken piece left in the blood specimen tube... | Class III | Biomedical Polymers, Inc. |
| Sep 11, 2019 | Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - ... | Due to low Quality Control recovery and invalid Calibration. | Class III | Roche Diagnostics Operations, Inc. |
| Sep 11, 2019 | Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: I... | Due to low Quality Control recovery and invalid Calibration. | Class III | Roche Diagnostics Operations, Inc. |
| Sep 5, 2019 | Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-8... | The touchpad may not work properly after cleaning. | Class III | CooperSurgical, Inc. |
| Aug 20, 2019 | FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IV... | The firm has identified that an incorrect instruction for use (IFU) revision was included in the ... | Class III | Biofire Defense |
| Aug 19, 2019 | LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical ... | Discrepancy between the correct expiration dates on the individual pouches inside the boxes and i... | Class III | CooperSurgical, Inc. |
| Aug 13, 2019 | EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100... | Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers. | Class III | Baxter Healthcare Corporation |
| Jul 25, 2019 | Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Prod... | Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range wa... | Class III | Randox Laboratories Ltd. |
| Jul 19, 2019 | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to... | Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause... | Class III | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jul 12, 2019 | This is an in vitro diagnostic product intended for use as a calibration seru... | Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for AL... | Class III | Randox Laboratories Ltd. |
| Jul 3, 2019 | LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected produc... | Perfusion tubing pack was packaged with the incorrect cuvette. | Class III | LivaNova USA Inc. |
| Jul 1, 2019 | Erisma- LP posterior fixation system with the below specifically affected pro... | Potential for the polyaxial screw to become disassembled during implant. | Class III | Clariance Inc |
| Jun 27, 2019 | EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 P... | EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers. | Class III | Baxter Healthcare Corporation |
| Jun 24, 2019 | TAPSYSTEM Model 2A, REF 8002A | There is a potential for an assembly error resulting in the battery wire being connected to the O... | Class III | Cardiocommand Inc. |
| Jun 10, 2019 | Assayed Bovine Multi-Sera Level 1, Model No. AL1027 | The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generat... | Class III | Randox Laboratories, Limited |
| Jun 7, 2019 | PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: ... | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a... | Class III | Polymer Technology Systems, Inc. |
| Jun 7, 2019 | Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Re... | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a... | Class III | Polymer Technology Systems, Inc. |
| Jun 4, 2019 | inLight Medical LED Pads used with Polychromatic light technology system | LED pads with cord connectors that have v-shaped notches may not have been assembled properly. Th... | Class III | Inlightened Partners LLC |
| 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 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 16, 2019 | Cepheid Xpert C. difficile/Epi Control Panel | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. | Class III | Microbiologics Inc |
| May 10, 2019 | CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Mode... | Possible corrosion of the battery contact(s). | Class III | Cardiocommand Inc. |
| May 10, 2019 | ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cab... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | Replacement ECG leadwires with snap ends REF/Catalog Number Description 210... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | Replacement leadwires with grabber ends: REF/Catalog Number Description 210... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| May 10, 2019 | Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 EC... | ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... | Class III | GE Healthcare, LLC |
| Apr 29, 2019 | Philips IntelliBridge System configured with a regional setting which uses a ... | Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ... | Class III | Philips North America, LLC |
| Apr 29, 2019 | Philips Patient Information Center iX configured with a regional setting whic... | Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ... | Class III | Philips North America, LLC |
| Apr 26, 2019 | Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D... | There is an error in the chromomap on the package insert. | Class III | Cytocell Ltd. |
| 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 |
| Apr 9, 2019 | ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Ca... | 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 | ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibr... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| Apr 9, 2019 | ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The AR... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| 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 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 1 - Product Usage: Multichem S Plus (Assaye... | Devices were delivered without the required dry ice. | Class III | Abbott Laboratories |
| Apr 4, 2019 | cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic s... | There is a potential for the tray input flap on the post analytical units to become loose, potent... | Class III | Roche Diagnostics Corporation |
| Apr 4, 2019 | SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085... | The manufacturer received complaints that customers were attempting to install the fitting softwa... | Class III | Advanced Bionics, LLC |
| Apr 4, 2019 | cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic s... | There is a potential for the tray input flap on the post analytical units to become loose, potent... | Class III | Roche Diagnostics Corporation |
| Apr 3, 2019 | 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 1... | Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72. | Class III | Fresenius Medical Care Renal Therapies Group, LLC |
| Mar 20, 2019 | Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Produ... | Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes | Class III | GETINGE US SALES LLC |
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.