Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 14, 2024 | Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of t... | Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods | Class II | Randox Laboratories Ltd. |
| Feb 14, 2024 | HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P... | Automated external defibrillators were shipped in their test configuration so there is a potentia... | Class II | HeartSine Technologies Ltd |
| Feb 14, 2024 | STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 | Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer repo... | Class II | Baxter Healthcare Corporation |
| Feb 14, 2024 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30... | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... | Class II | Covidien, LP |
| Feb 12, 2024 | Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal int... | Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation proce... | Class II | Sarnova HC, Llc |
| Feb 12, 2024 | Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intub... | Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation proce... | Class II | Sarnova HC, Llc |
| Feb 12, 2024 | Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument S... | There is a galling effect (cold-weld) caused by friction between the array fixation pins and the ... | Class II | Think Surgical, Inc. |
| Feb 9, 2024 | Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967 | Due to a manufacturing issue, the screw seat location on the abutment product may be too high, ca... | Class II | Preat Corp |
| Feb 8, 2024 | microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 11... | Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated thi... | Class II | Landauer |
| Feb 8, 2024 | Chromophare Surgical Light System , REF CH00000001 | Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. | Class II | Stryker Communications |
| Feb 8, 2024 | Access Total T4, REF 33800, IVD, thyroxine reagent assay. | Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specificati... | Class II | Beckman Coulter, Inc. |
| Feb 8, 2024 | Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Num... | Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may d... | Class II | EYE COMFORT CARE LLC |
| Feb 8, 2024 | Software VERIQA (S070031), version 2.0 and 2.1- Software package for display,... | Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold ... | Class II | PTW-FREIBURG |
| Feb 8, 2024 | CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DE... | Class II | Baxter Healthcare Corporation |
| Feb 7, 2024 | Torrent Suite Dx Software versions 5.14 and earlier used in connection with I... | Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems ex... | Class II | Life Technologies Corporation |
| Feb 7, 2024 | TENSIVE Conductive Adhesive Gel, REF 016-401600 | Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a vol... | Class II | Natus Neurology Inc |
| Feb 7, 2024 | Medtronic DLP Vessel Cannula, Model Number REF 30000 | Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP V... | Class II | Medtronic Perfusion Systems |
| Feb 7, 2024 | natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla ... | Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a vol... | Class II | Natus Neurology Inc |
| Feb 7, 2024 | Access Substrate, REF 81906, For use with the Access Immunoassay Systems | On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substra... | Class II | Beckman Coulter, Inc. |
| Feb 7, 2024 | DCA Systems HbA1c Reagent Kit | The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a po... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 6, 2024 | NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 7 9 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 6 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, ... | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, ... | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 6 10 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | Azurion 3 with a Certeray generator -To perform image guidance in diagnostic,... | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 6, 2024 | X3 TRIATHLON CS INSERT NO 3 10 MM | Potential packaging breaches of inner blister and outer sterile blister. | Class II | Howmedica Osteonics Corp. |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 5, 2024 | Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO | Their is a potential that electromagnetic interference may cause leadless pacemaker may result in... | Class II | Abbott Medical |
| Feb 5, 2024 | EasyPoint Needle, 25G x 5/8", REF: 82091 | The needle cannula of a retractable needle may detach from the needle holder in the patient. | Class II | Retractable Technologies, Inc. |
| Feb 2, 2024 | BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for ... | Pack and pouch label is missing the manufacturing and expiration date. | Class II | Beaver Visitec International, Inc. |
| Feb 1, 2024 | BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStatio... | Automated dispensing cabinets, running affected software, and Windows 10 operating system may exp... | Class II | CareFusion 303, Inc. |
| Jan 31, 2024 | Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbu... | Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to othe... | Class II | Randox Laboratories Ltd. |
| Jan 31, 2024 | Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin A... | Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to othe... | Class II | Randox Laboratories Ltd. |
| Jan 31, 2024 | Trumpet, Needle Guide, Cat# TMS-200 | The Ring on the Trump Needle Guide can detach when excessive pressure is applied. | Class II | Technicality Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percuta... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the p... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the pe... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutan... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutan... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutane... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutane... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | Epix Universal Clip Applier, REF: CA500, STERILEEO | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. | Class II | Applied Medical Resources Corp |
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.