Browse Device Recalls
3,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,029 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 3,029 FDA device recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ I... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL14... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class II | Focus Diagnostics Inc |
| Feb 10, 2016 | Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MO... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class I | Focus Diagnostics Inc |
| Feb 10, 2016 | Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL14... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class I | Focus Diagnostics Inc |
| Feb 10, 2016 | RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4... | A software issue with editing tools that use the left mouse button held down, for drawing in and ... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is util... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSp... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A dis... | eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, ... | Class II | Philips Electronics North America Corporation |
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aort... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMR... | Emergency helium venting lines (i.e. quench lines) may not have been properly installed. | Class II | Deerfield Imaging |
| Feb 10, 2016 | LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The Ligh... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternat... | Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovere... | Class II | Ambu Inc. |
| Feb 10, 2016 | LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner Syste... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable ... | eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, ... | Class II | Philips Electronics North America Corporation |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 9, 2016 | Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J... | Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and ... | Class II | Bard Peripheral Vascular Inc |
| Feb 9, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... | A report can be confirmed with the incorrect patient demographics resulting in it being saved und... | Class II | Merge Healthcare, Inc. |
| Feb 9, 2016 | Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicate... | Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and ... | Class II | Bard Peripheral Vascular Inc |
| Feb 9, 2016 | Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Eth... | Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intra... | Class II | Medtronic Neuromodulation |
| Feb 9, 2016 | Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge ... | Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecisi... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 8, 2016 | MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device | MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cann... | Class II | MicroAire Surgical Instruments, LLC |
| Feb 8, 2016 | MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula | Complaints that the cannula bent/broke during surgery. | Class II | MicroAire Surgical Instruments, LLC |
| Feb 8, 2016 | TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended t... | Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner... | Class II | Ormco/Sybronendo |
| Feb 5, 2016 | Vanguard XP Knee System Porous Femoral Component various sizes and orientat... | The anterior/posterior (AP) dimension may be oversized by 0.016. If the femoral component does... | Class II | Biomet, Inc. |
| Feb 5, 2016 | Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher | The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) we... | Class II | Stryker Medical Division of Stryker Corporation |
| Feb 5, 2016 | Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B... | A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possi... | Class II | Beckman Coulter Inc. |
| Feb 5, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Inc., H... | When measuring a lesion on an unmagnified mammography image then performing the same measurement ... | Class II | Merge Healthcare, Inc. |
| Feb 5, 2016 | Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cros... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: Thes... | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Co... | Class II | Volcano Corporation |
| Feb 5, 2016 | Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stret... | The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) we... | Class II | Stryker Medical Division of Stryker Corporation |
| Feb 5, 2016 | Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Ste... | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Co... | Class II | Volcano Corporation |
| Feb 5, 2016 | Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cr... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-s... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-se... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cro... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 4, 2016 | Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuid... | Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles becau... | Class II | Bard Peripheral Vascular Inc |
| Feb 4, 2016 | Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference)... | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Feb 4, 2016 | Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog... | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Feb 4, 2016 | 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user wit... | During an evaluation of the product packaging, it was determined that there is a potential for th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 4, 2016 | Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Nu... | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Feb 4, 2016 | 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user wit... | During an evaluation of the product packaging, it was determined that there is a potential for th... | Class II | Stryker Instruments Div. of Stryker 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.