Browse Device Recalls
389 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 389 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 389 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190. | 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 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V | Recent reports of patient infection. | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-MP190F. | 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, Model BF-Q180-AC | 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 Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP. | 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-UC180F & BF-UC190F. | 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 Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2. | 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-P190 & BF-XP190. | 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-MP160F, BF-XP160F, BF-XP60. | 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-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60... | 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 Tracheal Intubation Fiberscope, Models LF-P & LF-V. | 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-3C160. | 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-3C40 & BF-N20. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 20, 2023 | Visera Hysterovideoscope Olympus HYF Type V | IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brus... | Class II | Olympus Corporation of the Americas |
| Jul 12, 2023 | The Air/Water Valve is provided/used with the following Endoscopes: ULTRASON... | The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in lo... | Class II | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q1... | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150 | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60... | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | 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.