Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 12, 2021 | CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)0086... | Labeling does not include guidance for proper water-quality maintenance and device inspection fo... | Class II | CardioQuip, LLC |
| May 12, 2021 | Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and sh... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 11, 2021 | Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat,... | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| May 11, 2021 | Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each... | The HAT trial contains a retaining ring that has shown the potential to disengage during use. | Class II | Exactech, Inc. |
| May 11, 2021 | Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| May 11, 2021 | Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, R... | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| May 11, 2021 | Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| May 11, 2021 | Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounti... | Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time a... | Class II | Skytron, Div. The KMW Group, Inc |
| May 11, 2021 | novaplus, General Purpose Kit, Cat. No. 56603 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| May 10, 2021 | BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Cult... | Elevated rates of false negative results may occur when using blood culture panels due to issues ... | Class II | BioFire Diagnostics, LLC |
| May 10, 2021 | NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA ... | Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect va... | Class II | Randox Laboratories Ltd. |
| May 10, 2021 | EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit c... | A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from ... | Class II | IMPLANTCAST GMBH |
| May 10, 2021 | Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog ... | Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower funct... | Class II | Ventec Life Systems, Inc. |
| May 7, 2021 | DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrai... | Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number an... | Class II | DePuy Orthopaedics, Inc. |
| May 7, 2021 | Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 ... | Mislabeled product labeling references incorrect length or height, or length and height for speci... | Class II | K2M, Inc |
| May 7, 2021 | Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on system... | Class II | Beckman Coulter Inc. |
| May 7, 2021 | LeadCare II Blood Lead Test Kit Catalog Number 70-6762 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan Diagnostics, Inc. |
| May 7, 2021 | Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 ... | Mislabeled product labeling references incorrect length or height, or length and height for speci... | Class II | K2M, Inc |
| May 7, 2021 | Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 ... | Mislabeled product labeling references incorrect length or height, or length and height for speci... | Class II | K2M, Inc |
| May 7, 2021 | LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan Diagnostics, Inc. |
| May 7, 2021 | Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CC... | Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degre... | Class II | Zimmer GmbH |
| May 7, 2021 | LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 | Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... | Class I | Magellan Diagnostics, Inc. |
| May 7, 2021 | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on system... | Class II | Beckman Coulter Inc. |
| May 7, 2021 | Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CC... | Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degre... | Class II | Zimmer GmbH |
| May 6, 2021 | ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base... | Potential that a limited number of individual contact lens packages have an incomplete packaging ... | Class II | Johnson & Johnson Vision Care, Inc. |
| May 6, 2021 | Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS,... | Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem... | Class II | Corin Ltd |
| May 6, 2021 | Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hi... | Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem... | Class II | Corin Ltd |
| May 5, 2021 | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model... | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| May 5, 2021 | WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| May 5, 2021 | Omnera 400T Digital Radiographic System | There is the potential for the X-Ray system to short circuit due to an ingress of liquid in th... | Class II | Arcoma AB |
| May 5, 2021 | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Displ... | Due to a software error, the user may lose functionality of the system or the screen may turn bla... | Class II | Abbott Laboratories Inc. (St Jude Medical) |
| May 5, 2021 | Omnera 400A Digital Radiographic System | There is the potential for the X-Ray system to short circuit due to an ingress of liquid in th... | Class II | Arcoma AB |
| May 4, 2021 | Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 11000... | The component part numbers intended for shipment to a third-party, where they are further process... | Class I | Medtronic Vascular |
| May 4, 2021 | NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx... | There is a potential for false positive results when certain lots of cartridges are used in conju... | Class II | NeuMoDx Molecular Inc |
| May 4, 2021 | ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product ... | Software anomalies affecting the French, German and Italian versions of treatment delivery system... | Class II | Viewray, Inc. |
| May 4, 2021 | Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Materia... | Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 3, 2021 | VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemi... | Ortho investigated and confirmed the potential for unexpected failed calibration, and condition c... | Class II | Ortho-Clinical Diagnostics, INc. |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ... | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFligh... | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini ... | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GX... | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America 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.