Browse Device Recalls
1,092 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,092 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 1,092 FDA device recalls in OH.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jan 10, 2020 | AIA-360 Automated Immunoassay Analyzer, Product Code 019945 | A display screen software issue on the analyzer causes the display to freeze when display screen ... | Class II | Tosoh Bioscience Inc |
| Jan 3, 2020 | Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, D... | When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to... | Class II | Zimmer Surgical Inc |
| Dec 26, 2019 | Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Prod... | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Pr... | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo 924 Safety Screw Spike Set, Product Code 775759 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 11, 2019 | Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M123... | There is a potential for some systems built between 2014 and Jan 2018 to have a light output fall... | Class II | Lumitex Inc |
| Nov 15, 2019 | AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of ca... | The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack o... | Class III | Tosoh Smd Inc |
| Nov 15, 2019 | PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intende... | A defect involving an occluded needle was discovered during a training exercise. | Class I | Tytek Medical Inc |
| Nov 14, 2019 | Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 14, 2019 | S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent Syst... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 14, 2019 | Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent Sys... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 7, 2019 | Ligamax 5 mm Endoscopic Multiple Clip Applier | A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in... | Class II | Ethicon Endo-Surgery Inc |
| Oct 22, 2019 | Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 ... | Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (P... | Class II | Steris Corporation |
| Oct 22, 2019 | Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam | The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain ... | Class II | Steris Corporation |
| Oct 16, 2019 | Hitachi Scenaria Whole-body X-ray CT System | There is a possibility that the cables to the controller unit may not be affixed properly, creati... | Class II | Hitachi Medical Systems America Inc |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery 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.