Browse Device Recalls
38,658 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,658 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 38,658 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | Medtronic Perfusion Systems |
| Aug 6, 2025 | Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System | Inserter, used as part of a system with an intervertebral body fusion device, may contribute to d... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Aug 6, 2025 | ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. ... | Potential for undetected, deformed a-traumatic tips. | Class I | Olympus Corporation of the Americas |
| Aug 6, 2025 | Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit con... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and f... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. ... | Reports of out-of-box failures discovered during the limited launch phase. Failure modes included... | Class II | Maquet Cardiovascular, LLC |
| Aug 6, 2025 | Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | Medtronic Perfusion Systems |
| Aug 5, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Alcon Research LLC |
| Aug 5, 2025 | Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H749045... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Mod... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet ... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Alcon Research LLC |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Numb... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Lept... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 5, 2025 | Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 5, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Alcon Research LLC |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dres... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Alcon Research LLC |
| Aug 5, 2025 | Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number:... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Pinnacle Radiation Therapy Planning System: Multimodality Simulation Works... | Due to a software issue, there is a potential image error of the Region of Interest for expansion... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 5, 2025 | t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology,... | A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and ve... | Class II | Tandem Diabetes Care, Inc. |
| Aug 5, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Alcon Research LLC |
| Aug 5, 2025 | Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; ... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 4, 2025 | PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, ... | Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, lea... | Class II | Merit Medical Systems, Inc. |
| Aug 4, 2025 | Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit. | Potential for open header bag seals, compromising sterility. | Class II | AVID Medical, Inc. |
| Aug 4, 2025 | Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... | Class I | Baxter Healthcare Corporation |
| Aug 4, 2025 | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Modul... | On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously w... | Class II | Beckman Coulter Inc. |
| Aug 4, 2025 | Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... | Class I | Baxter Healthcare Corporation |
| Aug 4, 2025 | Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit. | Potential for open header bag seals, compromising sterility. | Class II | AVID Medical, Inc. |
| Aug 4, 2025 | Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... | Class I | Baxter Healthcare Corporation |
| Aug 4, 2025 | Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Mo... | Two new potential laser safety failure modes have been identified in the product design. Overcurr... | Class II | WASATCH PHOTONICS |
| Aug 1, 2025 | Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labele... | Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 1, 2025 | Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.... | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 1, 2025 | Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R... | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 31, 2025 | Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/Ti... | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security ... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 31, 2025 | Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-lumi... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording ... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mappin... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401... | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... | Class I | Medline Industries, LP |
| Jul 31, 2025 | Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Nam... | The potential of the elastic bands included in the kit detaching or fracturing during surgical pr... | Class II | Lumicell, Inc. |
| Jul 30, 2025 | Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introdu... | Units may have been packaged with an incorrect pouch label, which lists the reference number and ... | Class II | Contract Medical International GmbH |
| Jul 30, 2025 | IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT1... | Dental implants were imported under temperature and storage conditions that do not comply with th... | Class II | S.I.N. Implant System Ltda |
| Jul 30, 2025 | Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Num... | Due to a classification error in the inventory management system, specific medical devices were s... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jul 29, 2025 | WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; i... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific 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.