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 |
|---|---|---|---|---|
| May 25, 2018 | Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 25, 2018 | GE Healthcare CARESCAPE Monitor B650 | When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overlo... | Class II | GE Healthcare Finland Oy |
| May 25, 2018 | Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 25, 2018 | AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is ... | Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, w... | Class II | Siemens Medical Solutions USA, Inc |
| May 24, 2018 | FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 653... | During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar ... | Class II | Fort Defiance Industries, LLC |
| May 24, 2018 | STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1 | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | Discovery NM/CT 670 ES, model 5376204-70-57 | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot... | Class II | GE Healthcare, LLC |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEE... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No.... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FIL... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILT... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | CT Goldseal BrightSpeed 16 PWR TIO 2 YR | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Discovery RT labeled as: a. MID BJG; b. HVY BJG | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4... | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery NM/CT 670 Pro, model 5376204-70-54 | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckma... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers E... | Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is... | Class II | Zimmer Biomet, Inc. |
| May 24, 2018 | Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Dr... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalat... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Soft... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Revolution CT 160 1.5D STD WAUK | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inh... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PE... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhala... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usa... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND ... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILT... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | Optima CT 540 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FIL... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | Optima CT 520 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FIL... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 24, 2018 | Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, l... | When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Discovery MI Digital Ready | DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be ... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured b... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG ... | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | CT Goldseal Optima CT 600 | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILT... | There is a potential for the patient port retaining ring to not fully seat allowing the patient p... | Class II | Sun Med, LLC |
| May 23, 2018 | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation st... | Through an investigation, it has been determined that vials of Collagen packaged within the Colla... | Class III | Helena Laboratories, Corp. |
| May 23, 2018 | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studi... | Through an investigation, it has been determined that vials of Collagen packaged within the Colla... | Class III | Helena Laboratories, Corp. |
| May 23, 2018 | Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr.... | Product contains dry natural rubber latex. Label states Latex Free. | Class II | Arrow International Inc |
| May 23, 2018 | Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing... | This email is to provide notification that, due to a software bug that has been corrected, the Ra... | Class II | Ortho Kinematics, Inc |
| May 23, 2018 | Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003... | The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical ... | Class II | Steris Corporation |
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.