Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U There was an increase in complaints indicating an occurrence of system error E1226 "Could not wri... Class II Olympus Corporation of the Americas
Sep 3, 2024 GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo n... GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... Class I DATEX--OHMEDA, INC.
Sep 3, 2024 MR 7700 -For use as a diagnostic device to obtain cross-sectional images, sp... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 MR 5300 - For use as a diagnostic device to obtain cross-sectional images, sp... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional i... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with ... Product has been identified as having holes in the packaging. Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 3, 2024 SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cro... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cros... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional i... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obta... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-secti... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional im... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional image... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a st... The patient label stickers may have the wrong expiration date recorded. The contract manufacturer... Class III Trackx Technology Inc
Sep 3, 2024 GE Heathcare Giraffe OmniBed; neo natal incubator GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... Class I DATEX--OHMEDA, INC.
Sep 1, 2024 Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label corre... Class II SIN SISTEMA DE IMPLANTE NACIONAL S.A
Aug 30, 2024 Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal I... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 30, 2024 Predict+ is a data-driven, clinical decision support tool that uses machine l... Predict+ is being recalled for lack of pre-market clearance/approval. Class II Blue Ortho
Aug 30, 2024 IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 8... During a production process, Philips became aware of one IntelliVue power supply with a broken gr... Class II Philips North America
Aug 30, 2024 Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Inser... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 30, 2024 The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable st... Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instruct... Class II Stryker Neurovascular
Aug 30, 2024 LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 9... Due to an out of tolerance tool being used on monitor/defibrillator systems. Class II Physio-Control, Inc.
Aug 30, 2024 MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 30, 2024 Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Inserti... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 30, 2024 MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 30, 2024 Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angi... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 30, 2024 Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric em... Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. Class I Mercury Enterprises, Inc. dba Mercury Medical
Aug 30, 2024 MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 30, 2024 Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis V... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 30, 2024 Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9... The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unres... Class I Fresenius Kabi USA, LLC
Aug 30, 2024 Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographi... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 29, 2024 Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Steril... Specific lots of product have been manufactured with nonconforming raw materials. Class II Wilson-Cook Medical Inc.
Aug 29, 2024 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalo... GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (... Class II GE Healthcare
Aug 29, 2024 Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, f... Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled u... Class II Tornier, Inc
Aug 29, 2024 BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction ... Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience ... Class II CooperVision, Inc.
Aug 29, 2024 Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrum... Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobact... Class II Microcare Medical
Aug 29, 2024 Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the cor... Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience ... Class II CooperVision, Inc.
Aug 29, 2024 stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DW... One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max... Class II Tornier, Inc
Aug 28, 2024 MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840 Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent im... Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hor... Class II Beckman Coulter, Inc.
Aug 28, 2024 MEDLINE HEART CABG CDS, REF CDS983376R Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ... CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable En... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE OPEN HEART PACK, REF DYNJ66216C Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE OPEN HEART, REF DYNJ904261B Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE KIT CV I II, REF DYNJ906071B Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield

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.