Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jul 16, 2018 | AIIuraXperFDlO/10, System Code 722011 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 13, 2018 | Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OP... | OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula p... | Class II | Haemonetics Corporation |
| Jul 13, 2018 | Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 86... | Philips has received several reports in which monitors with lithium ion batteries that had exceed... | Class II | Philips Electronics North America Corporation |
| Jul 13, 2018 | Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286... | Philips has received several reports in which monitors with lithium ion batteries that had exceed... | Class II | Philips Electronics North America Corporation |
| Jul 13, 2018 | 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 20... | In the hemodialysis machine during the cleaning/disinfection program, when there is a power failu... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jul 13, 2018 | 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2... | In the hemodialysis machine during the cleaning/disinfection program, when there is a power failu... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jul 13, 2018 | Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 Ortho... | OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula p... | Class II | Haemonetics Corporation |
| Jul 13, 2018 | Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns V... | Philips has received several reports in which monitors with lithium ion batteries that had exceed... | Class II | Philips Electronics North America Corporation |
| Jul 13, 2018 | Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central m... | Philips has received several reports in which monitors with lithium ion batteries that had exceed... | Class II | Philips Electronics North America Corporation |
| Jul 13, 2018 | Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066... | Philips has received several reports in which monitors with lithium ion batteries that had exceed... | Class II | Philips Electronics North America Corporation |
| Jul 11, 2018 | TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T | The temperature sensor catheters may be defective in that they will show a lower body temperature... | Class II | COVIDIEN LLC |
| Jul 11, 2018 | 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywi... | The temperature sensor catheters may be defective in that they will show a lower body temperature... | Class II | COVIDIEN LLC |
| Jul 11, 2018 | P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS | The temperature sensor catheters may be defective in that they will show a lower body temperature... | Class II | COVIDIEN LLC |
| Jul 11, 2018 | 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywi... | The temperature sensor catheters may be defective in that they will show a lower body temperature... | Class II | COVIDIEN 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.