Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 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 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 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 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 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percu... | 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 10CM STIFF .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 4F X 10 CM STIFF .018 SS/SS 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 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the per... | 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 STIFF .018 NI/TU 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 | Epix Universal Clip Applier, REF: CA500, STERILEEO included within the follow... | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. | Class II | Applied Medical Resources Corp |
| Jan 30, 2024 | MINI STICK MAX 4F 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 STD .018 SS/PD 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 | MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG ... | 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 |
| 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 | 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 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 29, 2024 | NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessor... | Product is recalled due to reports of blood leaking or spraying from the arterial line on the car... | Class II | NxStage MDS Corporation |
| Jan 29, 2024 | Shimadzu, Trinias, Digital Angiography System | Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnorm... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Jan 29, 2024 | MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 | For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) val... | Class II | Canon Medical System, USA, INC. |
| Jan 29, 2024 | Embrace Drill Tower, Standard/Lateral (25mm) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 29, 2024 | Vantage Titan, Model: MRT-1504 | For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) val... | Class II | Canon Medical System, USA, INC. |
| Jan 29, 2024 | SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Ty... | Class II | Olympus Corporation of the Americas |
| Jan 29, 2024 | MRI system: Vantage Elan, Model: MRT-2020 | For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) val... | Class II | Canon Medical System, USA, INC. |
| Jan 29, 2024 | SOLTIVE Pro SuperPulsed Laser (TFL-SLS ) | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Ty... | Class II | Olympus Corporation of the Americas |
| Jan 29, 2024 | Embrace Drill Tower, Wedged (25mm) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 26, 2024 | VITROS XT 3400 Chemistry System, Catalog No. 6844458 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD B... | Due to a trend in false positive Candida tropicalis results on blood culture panel when using cer... | Class II | BioFire Diagnostics, LLC |
| Jan 26, 2024 | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refu... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 680291... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS XT 7600 Integrated System, Catalog No. 6844461 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 cause... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 | This Field Action is being conducted following the identification of a batch mix-up between I.B.S... | Class II | In2Bones, SAS |
| Jan 26, 2024 | VITROS XT 3400 Chemistry System, Catalog No. 6844458 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a b... | This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inv... | Class II | EMD Millipore Corporation |
| Jan 26, 2024 | I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 | This Field Action is being conducted following the identification of a batch mix-up between I.B.S... | Class II | In2Bones, SAS |
| Jan 26, 2024 | VITROS XT 7600 Integrated System, Catalog No. 6844461 | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (ref... | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC basel... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jan 26, 2024 | IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-8... | Due to reports of intraoperative graft bolt implantation breakages. | Class II | Alphatec Spine, Inc. |
| Jan 26, 2024 | FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-... | Due to potential signals of increased false positive Norovirus results when using the gastrointes... | Class II | BioFire Diagnostics, LLC |
| Jan 25, 2024 | SW Bari Lift & Transfer, Model Number 38060000 | Retrospective engineering analysis against current ISO standards for hoists has determined: 1. T... | Class II | Raye's Inc. |
| Jan 25, 2024 | IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) ... | Due to an error in the manufacturing process, it is possible that an incorrect plunger has been f... | Class II | Voco GmbH |
| Jan 25, 2024 | Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile,... | One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilizat... | Class II | Covidien, LP |
| Jan 25, 2024 | Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, ... | Due to an error in the manufacturing process, it is possible that an incorrect plunger has been f... | Class II | Voco GmbH |
| Jan 24, 2024 | TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) | Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd... | Class II | Siemens Healthcare Diagnostics, 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.