Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 25, 2022 | ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Mon... | The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. | Class II | Brainlab AG |
| Feb 15, 2022 | ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for... | When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range... | Class II | Ion Beam Applications S.A. |
| Feb 14, 2022 | Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 | Labelled with an incorrect expiry date on the outer label with an extended expiry date than the ... | Class III | Cytocell Ltd. |
| Feb 4, 2022 | TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a techniq... | May show unexpected locus specific signals in addition to those at 14q32. | Class III | Cytocell Ltd. |
| Jan 31, 2022 | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rap... | Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved,... | Class I | SD Biosensor, Inc. |
| Jan 20, 2022 | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; Yell... | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Class II | Surgical Innovations Ltd |
| Jan 20, 2022 | Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in lapar... | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Class II | Surgical Innovations Ltd |
| Jan 18, 2022 | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only | Incorrect marketing label (25 mm) was applied to product size 20 mm. | Class II | Merete Medical GmbH |
| Jan 18, 2022 | Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in c... | individual components have been labelled with incorrect colours. The red and green colours are op... | Class II | Cytocell Ltd. |
| Jan 11, 2022 | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/... | Retinal analysis system software has some features, based on artificial intelligence, that potent... | Class II | Diagnos Inc |
| Dec 30, 2021 | RayStation/RayPlan- designed for treatment planning and analysis of radiation... | If a new primary image set is selected while the cine loop is running, the primary image set will... | Class II | RAYSEARCH LABORATORIES AB |
| Dec 17, 2021 | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI... | One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. | Class III | LivaNova Deutschland GmbH |
| Dec 13, 2021 | The EnPlace is a single use trans-vaginal pelvic floor repair system which en... | Certain lots may not have been packaged wth the Channel Tube Limiter. | Class II | FEMSelect Ltd |
| Dec 10, 2021 | THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA | This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. Th... | Class II | Mallinckrodt Pharmaceuticals Ireland Ltd |
| Dec 8, 2021 | R82 by ETAC Push Brace for High-Low | The chrome surface of the push brace can crack during use, potentially cutting the user. | Class II | R82 A/S |
| Dec 8, 2021 | Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model ... | There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needl... | Class II | Technomed Europe |
| Dec 2, 2021 | Zenition 70, Model #718133 | Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 2, 2021 | Veradius Unity, Model #718132 | Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 2, 2021 | Zenition 50, Model #718096 | Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Nov 29, 2021 | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 | Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) ... | Class II | Ion Beam Applications S.A. |
| Nov 24, 2021 | DBB-06 Hemodialysis Delivery System | Device lacks premarket approval. | Class II | Nikkiso Ltd - Shizuoka Plant |
| Oct 14, 2021 | MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 | While cleaning or disinfecting the system, if the process is not followed as described in the man... | Class II | SEDECAL SA |
| Oct 11, 2021 | GM Helix Acqua Implant 3.5x10, Article No. 140.944 | 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone qual... | Class II | Jjgc Industria E Comercio De Materials Dentario... |
| Oct 4, 2021 | Cliquid MD version 3.4 software used in conjunction with Analyst MD software ... | The values of the Internal Standard (IS) concentrations are incorrectly derived when the user bui... | Class II | AB SCIEX |
| Oct 1, 2021 | REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... | There is a potential that the length of bone screws identified on labeling may not correspond to... | Class II | Limacorporate S.p.A |
| Oct 1, 2021 | Ellume COVID-19 Home Test | Due to a higher rate of false positive test results. | Class I | ELLUME LTD |
| Oct 1, 2021 | REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... | There is a potential that the length of bone screws identified on labeling may not correspond to... | Class II | Limacorporate S.p.A |
| Sep 28, 2021 | Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143;... | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed ... | Class II | ELEKTA SOLUTIONS AB |
| Sep 22, 2021 | RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations... | An issue where the combined density in a dose grid voxel partially covered by the External ROI an... | Class II | RAYSEARCH LABORATORIES AB |
| Sep 22, 2021 | ROSA One 3.1 Brain application The device is intended for the spatial posi... | The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which le... | Class I | MEDTECH SAS |
| Sep 10, 2021 | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different br... | The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to a... | Class II | Inpeco S.A. |
| Sep 9, 2021 | TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B... | If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or ... | Class II | RAYSEARCH LABORATORIES AB |
| Sep 2, 2021 | MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System | Under certain conditions, there is a risk for a false negative result. | Class II | BioMerieux SA |
| Aug 24, 2021 | McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 24, 2021 | McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 24, 2021 | McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, M... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 24, 2021 | HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 10... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 24, 2021 | McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, M... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 24, 2021 | HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 10... | Potential for difficulty in safety mechanism activation. | Class II | Zhejiang Kindly Medical Devices Co., Ltd. |
| Aug 11, 2021 | EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Red Medical Supplies |
| Aug 11, 2021 | EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Red Medical Supplies |
| Aug 11, 2021 | EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Red Medical Supplies |
| Aug 5, 2021 | AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product ... | Some devices may be associated with high and unexpected resistance to gas flow during clinical us... | Class I | Armstrong Medical Services Limited |
| Aug 2, 2021 | uMI 550 System - Product Usage: intended to be operated by qualified healthca... | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 2, 2021 | uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified... | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jul 30, 2021 | Arjo Disposable Repositioning Sling, Model AHD001 | Sling loop straps on device pose a trip hazard. | Class II | Getinge Dominican Republic SA |
| Jul 28, 2021 | Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 3... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 3... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, RE... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
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.