Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 19, 2024 | Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH0... | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure test... | Class II | Covidien LP |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (... | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... | Class II | Ad-Tech Medical Instrument Corporation |
| Sep 19, 2024 | Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 160478... | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - ... | Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical markin... | Class II | Novosource, LLC |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (... | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... | Class II | Ad-Tech Medical Instrument Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 V, Product code REF 1841050 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000, Product code REF 1841046 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (... | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... | Class II | Ad-Tech Medical Instrument Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 18, 2024 | A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-enc... | The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge... | Class II | Polymer Technology Systems, Inc. dba PTS Diagno... |
| Sep 18, 2024 | a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P... | The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System w... | Class II | Baxter Healthcare Corporation |
| Sep 18, 2024 | Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components... | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. | Class II | Medtronic Neuromodulation |
| Sep 18, 2024 | Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusabl... | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | Class II | Nihon Kohden America Inc |
| Sep 18, 2024 | Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in ... | Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached... | Class II | American Surgical Company, LLC |
| Sep 18, 2024 | Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 8090... | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | Class II | Nihon Kohden America Inc |
| Sep 18, 2024 | Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Na... | To better define the drying procedures described in the IFU to improve the instructions for easie... | Class II | Olympus Corporation of the Americas |
| Sep 17, 2024 | Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a ... | When PET-CT system is executing reconstruction, if PET acquisition for another patient is perform... | Class II | Canon Medical System, USA, INC. |
| Sep 17, 2024 | Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing L... | The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer pack... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Sep 17, 2024 | Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in mi... | A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in ... | Class II | Zimmer, Inc. |
| Sep 17, 2024 | MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-... | There is discrepant labeling on the inner and outer packaging of the device. | Class II | Datascope Corp. |
| Sep 17, 2024 | Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reus... | Due to pin coming off of handles. | Class II | MicroSurgical Technology Inc |
| Sep 17, 2024 | The IMAGEnet 6 Ophthalmic Data System is a software program that is intended ... | The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in th... | Class II | Topcon Medical Systems, Inc. |
| Sep 16, 2024 | Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Or... | Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complain... | Class II | Cook Incorporated |
| Sep 16, 2024 | The Graft Tube is an optional instrument which, as designed, can be filled wi... | Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used a... | Class II | Spineology, Inc. |
| Sep 16, 2024 | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ... | Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variab... | Class II | ImaCor Inc. |
| Sep 16, 2024 | Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 3... | Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal e... | Class II | Ambu Inc. |
| Sep 13, 2024 | EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12... | Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloo... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2024 | Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Num... | Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from t... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2024 | Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; | Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2024 | MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/A... | There is a potential for pinholes in the applicator pouch film which creates a sterility concern. | Class II | Integra LifeSciences Corp. |
| Sep 12, 2024 | Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: ... | Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control ... | Class II | Abbott Molecular, Inc. |
| Sep 12, 2024 | Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: ... | Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control ... | Class II | Abbott Molecular, Inc. |
| Sep 12, 2024 | BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.... | Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint f... | Class II | Becton Dickinson & Co. |
| Sep 11, 2024 | SynchroMed II Infusion Pump. Product Number: 8637-20 | Potential for error and inability to interrogate pump due to data corruption in the pump memory. | Class II | Medtronic Neuromodulation |
| Sep 11, 2024 | LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item N... | Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer... | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Sep 11, 2024 | Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sh... | Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the devi... | Class II | Olympus Corporation of the Americas |
| Sep 9, 2024 | iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 | There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. | Class II | Atrium Medical Corporation |
| Sep 6, 2024 | EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor... | Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, wh... | Class II | Enchroma Inc |
| Sep 6, 2024 | Enterprise Imaging XERO Viewer- software application used for reference and d... | Software defect, when an image has non-square pixel spacing, the reference/localizer line is inco... | Class II | Agfa Healthcare NV |
| Sep 6, 2024 | Trinias unity, Digital Angiography System with Catheterization Table, Model: ... | If digital angiography system is used with a specific catheterization table and the operator dire... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Sep 6, 2024 | The FLUOROspeed is intended to be used as a universal diagnostic imaging syst... | X-ray R/F system software with certain versions of the control board may occasionally fail to dis... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Sep 6, 2024 | Boston Scientific myLUX Patient Application for an Apple Mobile device, Mode... | Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhon... | Class II | Boston Scientific Corporation |
| Sep 6, 2024 | SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitabl... | X-ray R/F system software with certain versions of the control board may occasionally fail to dis... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | 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.