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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 4, 2026 | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2... | Product labeling includes a fetal indication for use that is not cleared under its 510(k). | Class II | Koven Technology, Inc. |
| Feb 18, 2026 | Cub Pediatric Crib, Model FL19H | Cribs sold in the USA are missing two access door warning labels. | Class II | Stryker Medical Division of Stryker Corporation |
| Feb 11, 2026 | BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be ... | Class II | CareFusion 303, Inc. |
| Feb 10, 2026 | Artegraft Vascular Graft; REF#: AG740; | Labeling mix-up resulting in the incorrect lot outer packaging of product. | Class II | LeMaitre Vascular, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Jan 21, 2026 | MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm... | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnet... | Class II | Stryker Corporation |
| Jan 21, 2026 | EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 | Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism wer... | Class II | Staar Surgical AG |
| Jan 16, 2026 | Private Label CVS. Model Number: CVS405406. Helps maintain a moist woun... | Potential packaging failures, which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Jan 15, 2026 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Mo... | Knee and Humeral socket implants contain incorrect labeling. | Class II | Encore Medical, LP |
| Jan 15, 2026 | MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010 | Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or ca... | Class II | KOB GmbH |
| Jan 15, 2026 | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUM... | Knee and Humeral socket implants contain incorrect labeling. | Class II | Encore Medical, LP |
| Jan 15, 2026 | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCK... | Knee and Humeral socket implants contain incorrect labeling. | Class II | Encore Medical, LP |
| Dec 31, 2025 | Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 ... | Products were mislabeled as the 6mm product but included the 5 mm product. | Class II | Centinel Spine, Inc. |
| Dec 31, 2025 | BEAR Implant. Model Number: 1000. | Incorrect expiration date on label that extends beyond the product's documented/approved shelf li... | Class II | Miach Orthopaedics |
| Dec 26, 2025 | Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CO... | Potential exposure of rodents and rodent activity in the distribution center. | Class II | GOLD STAR DISTRIBUTION INC |
| Dec 26, 2025 | Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE ... | Potential exposure of rodents and rodent activity in the distribution center. | Class II | GOLD STAR DISTRIBUTION INC |
| Dec 26, 2025 | Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, A... | Potential exposure of rodents and rodent activity in the distribution center. | Class II | GOLD STAR DISTRIBUTION INC |
| Dec 19, 2025 | TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number D... | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual scre... | Class II | Tornier, Inc |
| Dec 18, 2025 | Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE... | Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly... | Class II | Vascutek, Ltd. |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTREC... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTIC... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, ... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY ... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 15, 2025 | Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: M... | The console label for affected devices is missing the "DANGER" symbol. | Class II | LEASEIR TECHNOLOGIES SLU |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Ki... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, ... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIA... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes ... | Six (6) identified software issues which may result in the following: system keeps restarting, AM... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCO... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEU... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAK... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, ... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY,... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL L... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PA... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PO... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, K... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PA... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 11, 2025 | Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Ca... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 11, 2025 | Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 8, 2025 | Philips Azurion Systems R3.0. Includes the following label descriptions and c... | Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 4, 2025 | Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (C... | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Class II | Mobius Imaging, LLC |
| Dec 4, 2025 | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (C... | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Class II | Mobius Imaging, LLC |
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.