Browse Device Recalls

2,888 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,888 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 2,888 FDA device recalls in PA.

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DateProductReasonClassFirm
Dec 4, 2023 Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150... The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... Class II Olympus Corporation of the Americas
Dec 1, 2023 SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL... Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip a... Class II Olympus Corporation of the Americas
Nov 29, 2023 Sensis Vibe Hemo The possibility of the Sensis documentation functionality application to crash. Class II Siemens Medical Solutions USA, Inc
Nov 27, 2023 Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA21... The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is cont... Class II Philips Respironics, Inc.
Nov 20, 2023 OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S1... Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in t... Class II Olympus Corporation of the Americas
Nov 20, 2023 OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S1... Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in t... Class II Olympus Corporation of the Americas
Nov 13, 2023 CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S Possibility that the user is unable to resolve drill disconnection error messages. Class II Blue Belt Technologies, Inc
Nov 10, 2023 EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of st... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of st... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilati... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation o... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of ... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of st... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of stric... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of ... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of str... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 6, 2023 Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A ... Reports of a pink or green coloration of the image. If the issue is encountered during a procedur... Class II Olympus Corporation of the Americas
Nov 1, 2023 Infusomat Administration Sets as listed below: 362031 Infusomat Space Pu... In affected products, the tubing outer diameter may vary in size or the length of tubing may be t... Class I B. Braun Medical, Inc.
Oct 17, 2023 ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11... Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-... Class II Siemens Medical Solutions USA, Inc
Oct 12, 2023 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 12, 2023 EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 an... There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 12, 2023 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1T... There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 12, 2023 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 B... There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 12, 2023 EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190 There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 12, 2023 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... Class I Olympus Corporation of the Americas
Oct 5, 2023 Mobilett Mira wireless (VA20) mobile x-ray system(s) Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray a... Class II Siemens Medical Solutions USA, Inc
Oct 2, 2023 ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite Sy... Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. Class II Olympus Corporation of the Americas
Oct 2, 2023 EVIS EXERA III Gastrointestinal Videoscope Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of dry... Class II Olympus Corporation of the Americas
Sep 28, 2023 TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP Fiberscopes do not have adequate data to support that the suction flow rate meets the device spec... Class II Olympus Corporation of the Americas
Sep 26, 2023 BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration com... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use. Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids bet... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast manageme... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use ... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only.... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 25, 2023 Insufflation unit, UHI-4. Olympus has become aware of an increased trend of both repairs and customer complaints reporting ... Class II Olympus Corporation of the Americas
Sep 22, 2023 Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, dur... Class I Olympus Corporation of the Americas
Sep 21, 2023 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric ... Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... Class I B. Braun Medical, Inc.
Sep 21, 2023 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... Class I B. Braun Medical, Inc.
Sep 14, 2023 EVIS EXERA III Video System Center Model Number CV-190. Intended to be used w... Certain serial numbers of the CV-190 do not start up properly because parts that deviated from th... Class II Olympus Corporation of the Americas
Sep 12, 2023 THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indica... Thunderbeats blue seal button may remain in the engaged position after the button is released and... Class II Olympus Corporation of the Americas
Sep 12, 2023 THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indic... Thunderbeats blue seal button may remain in the engaged position after the button is released and... Class II Olympus Corporation of the Americas
Sep 12, 2023 Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed fo... Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirem... Class II Siemens Medical Solutions USA, Inc
Sep 12, 2023 ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray Sy... Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirem... Class II Siemens Medical Solutions USA, 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.