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 |
|---|---|---|---|---|
| Jan 29, 2016 | Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2... | Screws holding the detector panel in as a result the detector panel could make contact with othe... | Class II | Medtronic Navigation, Inc. |
| Jan 28, 2016 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-... | Incorrect femoral component distributed | Class II | ConforMIS, Inc. |
| Jan 20, 2016 | LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Prod... | LeadCare II Test Kits controls out of range | Class II | Magellan Diagnostics, Inc. |
| Jan 18, 2016 | Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 In... | On the label calcium (Ca) listed in the right upper corner of the label (red background) incorre... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jan 13, 2016 | Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 104... | The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 13, 2016 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer... | The Firm has discovered a Software bug. | Class II | Olympus Scientific Solutions Americas |
| Jan 13, 2016 | IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25... | The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 13, 2016 | Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490... | The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 13, 2016 | IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE... | The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 11, 2016 | Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical... | Blade exhibiting fracture during hip arthroscopy procedures | Class II | Smith & Nephew, Inc. |
| Jan 8, 2016 | DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radia... | In DS/US proton planning, there is a correction factor used internally to the dose engine that is... | Class II | Philips Medical Systems |
| Jan 4, 2016 | Philips IntelliVue Module Measurement X2 Model: M3002A | The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound ... | Class II | Philips Electronics North America Corporation |
| Jan 4, 2016 | Philips IntelliVue Measurement Module X1 Model: M3001A | The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound ... | Class II | Philips Electronics North America Corporation |
| Dec 29, 2015 | ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit)... | PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU). | Class II | Siemens Healthcare Diagnostics, Inc |
| Dec 18, 2015 | HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Co... | This Lot is not meeting labeled on-board instrument stability claims of 5 days. | Class II | Instrumentation Laboratory Co. |
| Dec 15, 2015 | Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR18... | The door latch may not fully close and the door may open unexpectedly. The door may make physica... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Dec 8, 2015 | Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wiz... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 347... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 T... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wiz... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 2, 2015 | PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01... | The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical... | Class II | Gsi Group Inc |
| Nov 25, 2015 | Philips Healthcare IntelliVue Info Center iX, A.0 866023 | Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w... | Class II | Philips Electronics North America Corporation |
| Nov 25, 2015 | Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, P... | Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w... | Class II | Philips Electronics North America Corporation |
| Nov 25, 2015 | Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Moni... | Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w... | Class II | Philips Electronics North America Corporation |
| Nov 23, 2015 | VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) | Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation b... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Nov 20, 2015 | FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 ... | Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Nov 20, 2015 | Cardinal Health Tiny Toes; 11470-010T Infant heel warmer | Heel warmers may cause first and second degree burns. | Class II | Philips Electronics North America Corporation |
| Nov 20, 2015 | FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Inte... | Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Nov 20, 2015 | FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 In... | Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Nov 20, 2015 | Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument ... | Manufacturing error within the Torque Handle may prohibit some handles from being able to fully a... | Class II | DePuy Spine, Inc. |
| Nov 18, 2015 | MEVION S250 Radiation therapy system | The treatment table positioning belt can slip gear positions, resulting in deviation of patient s... | Class II | Mevion Medical Systems, Inc. |
| Nov 11, 2015 | Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be use... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measuremen... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be use... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitativ... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in ... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be u... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 10, 2015 | MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The Med... | A small number of specific pumps may trigger a low battery alarm at the beginning of the implante... | Class II | Codman & Shurtleff, Inc. |
| Nov 10, 2015 | MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The Med... | A small number of specific pumps may trigger a low battery alarm at the beginning of the implante... | Class II | Codman & Shurtleff, Inc. |
| Nov 10, 2015 | Philips Healthcare DuraDiagnost stationary X-ray system | The detector may signal that it is ready for acquisition when it actually is not, resulting in f... | Class II | Philips Healthcare |
| Nov 10, 2015 | Philips Healthcare DigitalDiagnost stationary X-ray system | The detector may signal that it is ready for acquisition when it actually is not, resulting in f... | Class II | Philips Healthcare |
| Nov 3, 2015 | UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | 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.