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 |
|---|---|---|---|---|
| Feb 25, 2021 | In-View Clear Leggings Bulk Non-Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | Femoral Angiography Drape Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | Femoral Angiography Drape Bulk Non-Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an... | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... | Class I | Tenacore LLC |
| Feb 25, 2021 | In-View Clear Leggings Sterile Non-Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 25, 2021 | BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Mod... | Their is a potential that the automated staining instrument with software version 3.5.3.1 may mo... | Class II | Biocare Medical, LLC |
| Feb 25, 2021 | Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the col... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... | Class II | Fenwal Inc |
| Feb 25, 2021 | Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... | Class I | Tenacore LLC |
| Feb 25, 2021 | Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... | Class II | Fenwal Inc |
| Feb 25, 2021 | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equi... | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... | Class I | BioMedical Equipment Service Co (BMES) |
| Feb 25, 2021 | Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vi... | Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 m... | Class II | Dutch Ophthalmic USA, Inc. |
| Feb 25, 2021 | Amicus Exchange Kit - Product Usage: intended for use in the collection of bl... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... | Class II | Fenwal Inc |
| Feb 25, 2021 | In-View Clear Leggings Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufactur... | Class II | Cardinal Health 200, LLC |
| Feb 24, 2021 | Philips CT systems are advanced continuous-rotation computed tomography syste... | Philips has internally detected an issue with the actuators used in the Incisive CT couch, which ... | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Feb 24, 2021 | Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of fo... | The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. | Class II | Arthrex, Inc. |
| Feb 24, 2021 | KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged... | Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. | Class III | Microbiologics Inc |
| Feb 24, 2021 | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Periphe... | Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shor... | Class II | Access Vascular, Inc. |
| Feb 24, 2021 | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0... | Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. | Class III | Microbiologics Inc |
| Feb 23, 2021 | Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended ... | Evidence of face masks or other material in the seal in several kits, causing improper seals and ... | Class II | Trinity Sterile, Inc. |
| Feb 22, 2021 | Incisive CT Computed Tomography X-ray System Model: 728143 | Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2... | Class II | Philips North America Llc |
| Feb 22, 2021 | Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 ... | BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Feb 22, 2021 | RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7,... | For some LINAC types, merging clinical beams with beams of approximate dose may lead to the appro... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter,... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, ... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for s... | There is a potential presence of particulate matter in the D-Vial. | Class II | Sirtex Medical Limited |
| Feb 22, 2021 | Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Produc... | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Feb 22, 2021 | The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Produc... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... | Class II | DePuy Orthopaedics, Inc. |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve,... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consist... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... | Class II | DePuy Orthopaedics, Inc. |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually package... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... | Class II | DePuy Orthopaedics, Inc. |
| Feb 22, 2021 | EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.... | It has been identified that the catheter size on the packaging labeling does not correspond to th... | Class II | EPIX THERAPEUTICS, INC |
| Feb 22, 2021 | AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer... | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Feb 19, 2021 | Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Micro... | Malfunction of the robotic arm preventing further movement of the robotic arm and requiring resta... | Class II | Aesculap Implant Systems LLC |
| Feb 18, 2021 | SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70... | The product may be contaminated with Burkholderia cepacia | Class II | Sunstar Americas, Inc. |
| Feb 18, 2021 | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi... | Customers are being notified of results from a Toxicological Risk Assessment related to potential... | Class I | Smisson-Cartledge Biomedical, LLC |
| Feb 18, 2021 | ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit | Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DC... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Feb 18, 2021 | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi... | Customers are being notified of results from a Toxicological Risk Assessment related to potential... | Class I | Smisson-Cartledge Biomedical, LLC |
| Feb 18, 2021 | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedi... | Customers are being notified of results from a Toxicological Risk Assessment related to potential... | Class I | Smisson-Cartledge Biomedical, LLC |
| Feb 18, 2021 | RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visual... | Teleflex is voluntarily recalling the products referenced above due to customers reporting that t... | Class II | TELEFLEX MEDICAL INC |
| Feb 18, 2021 | VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only).... | Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will sta... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Feb 16, 2021 | EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - ... | Contact lenses may be mislabeled with the incorrect lens power. | Class II | Clerio Vision |
| Feb 16, 2021 | MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE... | Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon ... | Class II | Vectornate USA Inc |
| Feb 15, 2021 | Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Pr... | The mirror may become detached and fall from the unit | Class II | CARESTREAM DENTAL, LLC |
| Feb 12, 2021 | NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System ... | Due to not having the full complement of biological assessments for all potential patients and as... | Class II | Nuvasive Specialized Orthopedics Inc |
| Feb 12, 2021 | PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter i... | Teleflex is recalling this product due to a lack of assurance of sterility. | Class II | TELEFLEX MEDICAL INC |
| Feb 12, 2021 | Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesio... | Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. | Class I | Medtronic Vascular, Inc. |
| Feb 12, 2021 | Precice Bone Transport - Product Usage: intended for limb lengthening, open... | Due to complaints of adverse events potentially related to biological safety. The complaints inc... | Class II | Nuvasive Specialized Orthopedics Inc |
| Feb 12, 2021 | NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening Syst... | Due to not having the full complement of biological assessments for all potential patients and as... | Class II | Nuvasive Specialized Orthopedics 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.