Browse Device Recalls

1,062 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,062 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 1,062 FDA device recalls in OH.

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DateProductReasonClassFirm
Dec 15, 2021 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Nov 22, 2021 Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 This recall has been initiated to provide a labeling update with revised instruction how to opera... Class II Gentherm Medical, LLC
Nov 12, 2021 Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Modul... Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... Class II Invacare Corporation
Nov 12, 2021 Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model... Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... Class II Invacare Corporation
Nov 12, 2021 Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Mod... Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... Class II Invacare Corporation
Nov 3, 2021 OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the la... Class II Haag-Streit USA Inc
Nov 3, 2021 OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the la... Class II Haag-Streit USA Inc
Oct 16, 2021 Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840 VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 16, 2021 Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600 VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 16, 2021 Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS... VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 16, 2021 Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS... VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 14, 2021 Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, ... Class II FujiFilm Healthcare Americas Corporation
Oct 14, 2021 Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a F... Class II FujiFilm Healthcare Americas Corporation
Oct 14, 2021 Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a F... Class II FujiFilm Healthcare Americas Corporation
Oct 14, 2021 Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a F... Class II FujiFilm Healthcare Americas Corporation
Oct 11, 2021 Affected components are limited to the Monoprice charging cable (Product # 48... Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause ... Class II Forbes Rehab Services Inc
Aug 20, 2021 LiquaSonic Ultrasound Gel 5L, Model No. 001222 Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Athena Medical Products Inc
Aug 20, 2021 LiquaSonic Ultrasound Gel 250mL, Model No. 001205 Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Athena Medical Products Inc
Aug 13, 2021 Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The ... Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral lo... Class II Quidel Corporation
Jul 29, 2021 ECHELON Oval MRI System There was no label on the pad packaging or notification in the user manual that the table pads c... Class II Hitachi Healthcare Americas Corporation
Jul 29, 2021 ECHELON MRI System There was no label on the pad packaging or notification in the user manual that the table pads c... Class II Hitachi Healthcare Americas Corporation
Jul 29, 2021 OASIS MRI System There was no label on the pad packaging or notification in the user manual that the table pads c... Class II Hitachi Healthcare Americas Corporation
Jul 20, 2021 HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisi... An internal component may be cracked and become lodged behind the energy button potentially resul... Class II Ethicon Endo-Surgery Inc
Jul 20, 2021 HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisio... An internal component may be cracked and become lodged behind the energy button potentially resul... Class II Ethicon Endo-Surgery Inc
Jun 30, 2021 Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation duri... The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. ... Class II Hitachi Healthcare Americas Corporation
Jun 17, 2021 Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. ... There is a potential risk of device contamination and patient infection associated with the devic... Class II Gentherm Medical, LLC
Jun 3, 2021 ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or... Mislabeled: Labeled on the package as 60mm contains 45mm devices Class II Ethicon Endo-Surgery Inc
Apr 27, 2021 Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent In rare situations patients infected with high viral load of SARS CoV 2 may have samples that gen... Class I Quidel Corporation
Apr 20, 2021 Alpha Interlock Suspension System Lanyard Body: An external prosthetic device... the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8... Class II WillowWood Global Llc
Apr 15, 2021 Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicros... Examination data and patient name may be mixed up when printing or generating a pdf with the inte... Class II Haag-Streit USA Inc
Apr 8, 2021 Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalo... Emergency Use Application (EUA) application withdrawn as false negative results reported Class II Meridian Bioscience Inc
Apr 8, 2021 Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Tra... Emergency Use Application (EUA) application withdrawn as false negative results reported Class II Meridian Bioscience Inc
Mar 18, 2021 Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted in... The incorrect dental pins were packaged and subsequently distributed. Class II Coltene Whaledent Inc
Mar 16, 2021 ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 FREESTYLE LANCETS 28G 100CT Item Number:2975670 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 BD UF PEN 32GX4MM 100 NANO Item Number: 4292272 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 VAPORIZER VICKS 1.5GAL Item Number: 2354942 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 DEXCOM G6 SENSOR 3 PACK Item Number: 5447552 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health Inc.
Mar 16, 2021 ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862 Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent... Class II Cardinal Health 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.