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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Date	Product	Reason	Class	Firm
Mar 16, 2021	OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326	Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittent...	Class II	Cardinal Health Inc.
Mar 1, 2021	Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by...	Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transdu...	Class II	Hitachi Medical Systems America Inc
Feb 8, 2021	The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in...	Use of the kits after incorrect storage could lead to a potential false-negative or invalid resul...	Class II	Meridian Bioscience Inc
Jan 21, 2021	OT1000 Series Orthopedic Surgical Tables	On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assem...	Class II	Steris Corporation
Dec 11, 2020	Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended f...	The electrical contactor component present in the drying chamber of the Reliance Vision Single-Ch...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas...	Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam ...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per cas...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Nov 20, 2020	Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref ...	Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered b...	Class II	Haag-Streit USA Inc
Nov 19, 2020	Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrumen...	STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseu...	Class II	Steris Corporation
Nov 10, 2020	AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102...	The products subject to this recall may contain obvious, incorrect pouch labels while the outer b...	Class III	Applied Medical Technology Inc
Nov 5, 2020	ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Cat...	Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests	Class II	VEO DIAGNOSTICS, LLC
Oct 30, 2020	Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respirat...	Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization...	Class II	Invacare Corporation
Oct 20, 2020	Strauss 25 Carbide Dental Burs (100057XXV)	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi...	Class II	Coltene Whaledent Inc
Oct 20, 2020	Clinic Pack 100 Pieces FG 57 100057C (100057C)	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi...	Class II	Coltene Whaledent Inc
Oct 20, 2020	Alpen Clinic 100 Carbide Instruments (R100057C)	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi...	Class II	Coltene Whaledent Inc
Oct 20, 2020	FG 57 100057X (100057X)	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi...	Class II	Coltene Whaledent Inc
Oct 20, 2020	CEI Cutting Edge Instruments (PTC-57C)	The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi...	Class II	Coltene Whaledent Inc
Oct 7, 2020	Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid ...	Potential for cleaning solution intrusion into endoscope	Class III	Steris Corporation
Oct 5, 2020	TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended f...	Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompressio...	Class II	Tytek Medical Inc
Oct 5, 2020	TyTek PneumoDart- Intended for introduction into the body to facilitate remov...	Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompressio...	Class II	Tytek Medical Inc
Oct 5, 2020	TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for i...	Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompressio...	Class II	Tytek Medical Inc
Sep 7, 2020	Neoprobe GDS Control Unit, Model Number NPCU3	It was discovered during a documentation review that China has the software version as v5.01 appr...	Class III	Devicor Medical Products Inc
Aug 13, 2020	Critical Care Decontamination System (CCDS) Compatible N95 respirators - Pr...	Masks processed at one site were not maintained at levels of condensation during a portion of the...	Class II	Battelle Memorial Institute
Aug 7, 2020	Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG P...	Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, ...	Class II	Tosoh Bioscience Inc
Aug 7, 2020	Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Dia...	Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, ...	Class II	Tosoh Bioscience Inc
Jul 31, 2020	Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC,...	Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.	Class II	Klarity Medical Products LLC
Jun 26, 2020	InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ul...	A recent FDA inspection at the firm identified that the foil test performed during installation o...	Class II	Steris Corporation
Jun 3, 2020	HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam fo...	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it...	Class II	Coltene Whaledent Inc
Jun 3, 2020	HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam ...	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it...	Class II	Coltene Whaledent Inc
Jun 3, 2020	HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam f...	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it...	Class II	Coltene Whaledent Inc
Jun 3, 2020	HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam...	Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it...	Class II	Coltene Whaledent Inc
May 22, 2020	AIA-900 Analyzer, Part no. 022930, UDI 04560189283992	The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle....	Class II	Tosoh Bioscience Inc
May 14, 2020	Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number:...	Kit contained an incorrect catheter-tip syringe not compatible with the luer lock connector of ...	Class II	Bound Tree Medical
Apr 20, 2020	Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product ...	Three products requiring refrigerated storage conditions were incorrectly stored outside of appro...	Class II	Cardinal Health Inc.
Apr 20, 2020	B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is...	Three products requiring refrigerated storage conditions were incorrectly stored outside of appro...	Class II	Cardinal Health Inc.
Apr 20, 2020	Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere P...	Three products requiring refrigerated storage conditions were incorrectly stored outside of appro...	Class II	Cardinal Health Inc.
Feb 11, 2020	NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T	Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging	Class II	Nelson Innovaions, Llc
Jan 31, 2020	UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 pro...	These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus r...	Class II	Hitachi Medical Systems America 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.