Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 17, 2017 | ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units... | Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from ... | Class II | Philips Electronics North America Corporation |
| Jul 17, 2017 | Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon... | Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable s... | Class II | Covidien LP |
| Jul 14, 2017 | TD60 Transmitter battery charger used with the BeneVision Central Station, Pa... | A damaged circuit board in the battery charger can cause the battery to overcharge and the batter... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 14, 2017 | Mobile Detector Holder - Stationary X-ray System (RF System). suitable for po... | If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly ... | Class II | Philips Electronics North America Corporation |
| Jul 14, 2017 | A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3)... | A software issue may result in the previous settings being applied instead of the default setting... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 14, 2017 | Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s... | There was a case that the swivel arm went down unintentionally when it was moved up/down. | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jul 14, 2017 | Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, R... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intende... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is int... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody i... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is in... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 14, 2017 | PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3 | The lift motor used to raise and lower the overhead chassis will wear if not properly maintained ... | Class II | Panoramic Rental Corp. |
| Jul 14, 2017 | A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) ... | A software issue may result in the previous settings being applied instead of the default setting... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 14, 2017 | ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital M... | There was a case that the swivel arm went down unintentionally when it was moved up/down. | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jul 14, 2017 | MyCareLink Patient Monitors. It is intended for used with a compatible Med... | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jul 14, 2017 | MyCareLink Smart Patient Monitors. It is intended for use with a compatibl... | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jul 14, 2017 | Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is inte... | A delay in transit may have contributed to nonconformity as the product was stored outside of def... | Class II | Leica Biosystems Richmond Inc. |
| Jul 13, 2017 | Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumin... | Stylette removal difficulties on the Euphora and Solarice products. | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Jul 13, 2017 | THERMI250 Radiofrequency System. Intended to provide heating for the purpo... | In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. | Class II | Bios S.r.l. |
| Jul 13, 2017 | CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitor... | Device does not produce a visual or audible impedance respiration APN alarm when an impedance res... | Class II | GE Medical Systems Information Technologies, Inc. |
| Jul 13, 2017 | Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumi... | Stylette removal difficulties on the Euphora and Solarice products. | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Jul 13, 2017 | Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W2... | The firm received several customer complaints reporting some perioperative breakages of NE0411 No... | Class II | In2Bones, SAS |
| Jul 13, 2017 | The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew L... | The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a s... | Class II | Microline Surgical, Inc. |
| Jul 13, 2017 | BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is pa... | Potential for intermittent lighting (flickering) during use. | Class II | Bomimed |
| Jul 13, 2017 | Video Cystoscope models ECY-1570 and ECY-1570K | The video cytoscopes lack 510(k) premarket notification clearance. | Class II | Pentax of America Inc |
| Jul 12, 2017 | CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S... | Class II | DePuy Orthopaedics, Inc. |
| Jul 12, 2017 | VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent card... | Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizin... | Class II | Biomerieux Inc |
| Jul 12, 2017 | CORAIL HIGH OFFSET STEM Collarless SIZE 14 | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S... | Class II | DePuy Orthopaedics, Inc. |
| Jul 12, 2017 | MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 ... | Affected units may have a defective component that is intended to protect the internal circuitry ... | Class I | Philips North America, LLC |
| Jul 12, 2017 | VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and... | Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizin... | Class II | Biomerieux Inc |
| Jul 11, 2017 | Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool | Vix Bit may fracture during use. | Class II | Exactech, Inc. |
| Jul 11, 2017 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analy... | Instruments may, under certain specific circumstances listed below, fail to stop when a test is i... | Class II | Olympus Scientific Solutions Americas |
| Jul 11, 2017 | Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tom... | Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, da... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 11, 2017 | Brilliance iCT - Model 728306 Computed Tomography X-ray systems | Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, da... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 10, 2017 | Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to ... | Two specific lots was incorrectly manufactured containing a UK power adapter. | Class III | AMEDA, INC. |
| Jul 10, 2017 | THREAD RETRIEVAL DRILL REF 2224 | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOC... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, RE... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | VITROS Chemistry Products Performance Verifier is used as an assayed control ... | VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements fo... | Class III | Ortho Clinical Diagnostics Inc |
| Jul 10, 2017 | ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPI... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device p... | Needle supplier indicated the presence of loose polypropylene foreign matter above release specif... | Class II | Arrow International Inc |
| Jul 10, 2017 | Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, R... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 7, 2017 | Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 | The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Ac... | Class II | Hologic, Inc. |
| Jul 7, 2017 | Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-dr... | Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Var... | Class II | Amendia, Inc |
| Jul 7, 2017 | Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery... | The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective ... | Class II | Ondamed Inc |
| Jul 7, 2017 | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog nu... | Specific lots have been reported to produce falsely lower than expected results for Vitamin D | Class II | Qualigen Inc |
| Jul 7, 2017 | Mac Pin Non-Cannulated Screw, 6.5 x 60mm | Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, t... | Class II | Amendia, Inc |
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.