Browse Device Recalls
5,540 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,540 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 5,540 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 3, 2025 | C8-5 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | S9-2 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | X7-2 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | L9-3 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | C8-4v Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | L12-5 38mm Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | C6-2 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jul 3, 2025 | TRANSDUCER L12-5 Transducer Probe | To provide clarification and labelling to define the useful life of ultrasound transducers in the... | Class III | Philips Ultrasound, Inc |
| Jun 30, 2025 | Laser light show projectors manufactured by BLS, Model PURE 5000/10000. | The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... | Class II | Beyond Laser Systems, LLC |
| Jun 30, 2025 | Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000. | The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... | Class II | Beyond Laser Systems, LLC |
| Jun 30, 2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SC... | Cannulated fenestrated polyaxial screws may be incorrectly labeled | Class II | SPINEART SA |
| Jun 30, 2025 | Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000. | The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... | Class II | Beyond Laser Systems, LLC |
| Jun 30, 2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SC... | Cannulated fenestrated polyaxial screws may be incorrectly labeled | Class II | SPINEART SA |
| Jun 27, 2025 | Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg... | Device does not comply with the labeling requirements of international standard IEC 60601-1. | Class II | Maquet Cardiopulmonary Gmbh |
| Jun 26, 2025 | UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, | Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting... | Class II | Beckman Coulter Inc. |
| Jun 25, 2025 | DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combinati... | Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Pot... | Class II | Nuclein LLC |
| Jun 24, 2025 | PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-37... | A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect... | Class II | Orthofix U.S. LLC |
| Jun 23, 2025 | Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:... | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... | Class I | Thoratec LLC |
| 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. |
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.