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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.