Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 30, 2018 | Mitek Screw and Washer Depth Gauge, Product Code 219024 | The device has an offset in the design that results in a reading approximately 3.2mm shorter than... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 1... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT R... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK,... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 30, 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, M... | Software anomalies were reported to affect the following system functionalities: startup and shut... | Class II | Medtronic Navigation, Inc.-Littleton |
| Aug 17, 2018 | EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28... | The firm identified the potential for a device to have an incorrect tissue gap. Use of a device w... | Class II | COVIDIEN LLC |
| Aug 16, 2018 | Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 | Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflec... | Class III | Medtronic Vascular |
| Aug 8, 2018 | Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement ... | Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values... | Class II | Magellan Diagnostics, Inc. |
| Aug 1, 2018 | Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - ... | There is a potential for increased imprecision, out of range quality controls and prolonged sampl... | Class II | Instrumentation Laboratory Co. |
| Aug 1, 2018 | Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Aug 1, 2018 | AIRO Mobile CT System Model # MobiCT-32 | The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with softwar... | Class II | Mobius Imaging, LLC |
| Aug 1, 2018 | Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), ... | Potential for product sterility breach due to a compromised or pinched seal defect | Class II | COVIDIEN LLC |
| Jul 24, 2018 | ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2018 | ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: ... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2018 | Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: ... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2018 | ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vit... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 24, 2018 | Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vit... | A potential bias was identified with certain kits compared to the internal standards. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 19, 2018 | Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model ... | A small number of devices in this lot may have a melted cap and a hole formed through the packagi... | Class II | Beaver Visitec |
| Jul 16, 2018 | Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurova... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovasc... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascu... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurov... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascula... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovas... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular an... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular ... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular an... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular an... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurov... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neur... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular ... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurova... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular ... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurova... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular an... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovasc... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neuro... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America Corporation |
| Jul 16, 2018 | INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascula... | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may... | Class II | Philips Electronics North America 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.