Browse Device Recalls

3,367 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,367 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 3,367 FDA device recalls in IL.

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DateProductReasonClassFirm
Jul 13, 2023 Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NO... Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... Class II Carefusion 2200 Inc
Jul 13, 2023 Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, R... Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... Class II Carefusion 2200 Inc
Jul 13, 2023 Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM,... Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... Class II Carefusion 2200 Inc
Jul 13, 2023 Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETE... Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... Class II Carefusion 2200 Inc
Jul 13, 2023 Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED,... Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... Class II Carefusion 2200 Inc
Jul 12, 2023 NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Do... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 181... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation mon... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OT... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNA... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation moni... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-K... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation moni... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with th... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitor... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b)... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation moni... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3M... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNA... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation m... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation mon... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dos... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation moni... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitor... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 The following Pro.specta Emission Computed Tomography Systems that were manuf... During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive ... Class II Siemens Medical Solutions USA, Inc.
Jul 12, 2023 Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OT... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 3, 2023 Total Hip Kit, REF DYNJ903275S; surgical convenience kit The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit. Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 19, 2023 GEM FLOW COUPLER Monitor, PN 5156-00000-011 An issue was identified where the LCD monitor display may not indicate the correct active channel... Class II Baxter Healthcare Corporation
Jun 16, 2023 NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V1146... Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regard... Class II Cardinal Health 200, LLC
Jun 15, 2023 SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ... Class I Baxter Healthcare Corporation
Jun 15, 2023 The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35... A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ... Class I Baxter Healthcare Corporation
Jun 5, 2023 Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... Class II Luminex Corporation

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.