Browse Device Recalls

407 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 407 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 407 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 11, 2024 Colonoscope, Model Number PCF-H180AL. Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... Class II Olympus Corporation of the Americas
Jan 11, 2024 Colonoscope, Model Number CF-H180AL. Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... Class II Olympus Corporation of the Americas
Jan 11, 2024 Colonoscope, Model Number CF-Q180AL. Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... Class II Olympus Corporation of the Americas
Jan 11, 2024 Colonoscope, Model Number PCF-H190DL. Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... Class II Olympus Corporation of the Americas
Jan 5, 2024 Hemostasis Probe, Model: CD-B622LA The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a... Class II Olympus Corporation of the Americas
Dec 15, 2023 ESG PK CUTTING FORCEPS, 5MM, 33CM The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or duri... Class II Olympus Corporation of the Americas
Dec 11, 2023 Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilat... The expiration date is missing from the primary (inner) packaging. The secondary (outer) box labe... Class II Olympus Corporation of the Americas
Dec 8, 2023 Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope ... Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result ... Class II Olympus Corporation of the Americas
Dec 4, 2023 Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... Class II Olympus Corporation of the Americas
Dec 4, 2023 SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch se... Class II Olympus Corporation of the Americas
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 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 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
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 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 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 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
Aug 10, 2023 Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for ... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Aug 10, 2023 Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SP... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Aug 10, 2023 Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 2... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Aug 10, 2023 Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Naviga... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Aug 10, 2023 Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Univ... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Aug 10, 2023 Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12... Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... Class II Olympus Corporation of the Americas
Jul 27, 2023 Olympus Airway Mobilescope, Models MAF-GM & MAF-TM. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... Class II Olympus Corporation of the Americas
Jul 27, 2023 Olympus Bronchovideoscope, Models BF-XT190. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... Class II Olympus Corporation of the Americas
Jul 27, 2023 Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... Class II Olympus Corporation of the Americas

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.