Browse Device Recalls

5,321 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,321 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 5,321 FDA device recalls.

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DateProductReasonClassFirm
Jun 23, 2025 BD COR System Software. Model Number: 444829. Potential for functionality issue that supports the Over labeling feature and could lead to poss... Class II Becton Dickinson & Co.
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... Class I Thoratec LLC
Jun 18, 2025 Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard e... Natus received two complaints of left side labeling show impedance for right side. Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 11, 2025 HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for us... The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... Class II CooperSurgical, Inc.
Jun 11, 2025 Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Con... The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... Class II CooperSurgical, Inc.
Jun 11, 2025 Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. End... The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... Class II CooperSurgical, Inc.
Jun 10, 2025 VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 ... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 10, 2025 VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 sli... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 10, 2025 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 10, 2025 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... Class II Ortho-Clinical Diagnostics, Inc.
Jun 4, 2025 Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Numbe... An incoming complaint reported that the expiration date on the kit box label and Certificate of A... Class III DRG International, Inc.
Jun 4, 2025 Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date... Class III Diversatek Healthcare
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... Class II Encore Medical, LP
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... Class II Encore Medical, LP
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... Class II Encore Medical, LP
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... Class II Encore Medical, LP
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 22, 2025 Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left... Class II Stryker GmbH
May 22, 2025 Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left... Class II Stryker GmbH
May 15, 2025 Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnosti... Cook Medical identified that catheters supplied in the affected device lots may experience tip se... Class I Cook Incorporated
May 13, 2025 Lago X The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not c... Class II Spectral Instruments Inc
May 13, 2025 Ami HTX. The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not c... Class II Spectral Instruments Inc
May 12, 2025 The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue G... Glucose microcuvettes experienced transit time outside of limits, so stability through the whole ... Class II HemoCue AB
May 7, 2025 Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM0000... Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
May 7, 2025 Medtronic, Simplera Sensor, REF: MMT-5100JD1 The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and ... Class II Medtronic MiniMed, Inc.
May 2, 2025 Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catal... Due to labeling error. Product incorrectly labeled. Class II Canary Medical, Inc.
May 1, 2025 GM Helix Acqua Implant, Article Number: 140.985 It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. Class II Straumann USA LLC
May 1, 2025 GM Helix Acqua Implant, Article Number: 140.984 It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. Class II Straumann USA LLC
Apr 25, 2025 AcoSound. Model Number: LW12-BTE-M Three issues 1. Label error: The manufacturer information in the labeling is not correct, the m... Class III HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
Apr 24, 2025 ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAG... transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST... transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50B... transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office

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.