Browse Device Recalls
423 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 423 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 423 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jun 8, 2023 | Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 | 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, Model Numbers BF-Q170 | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | HF Resection Electrodes - HF resection electrodes are part of a resectoscope ... | Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end... | Class II | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q... | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| May 26, 2023 | Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disi... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway managemen... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level di... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level dis... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 19, 2023 | UroPass Ureteral Access Sheaths, 5 pieces/box | Dilator tips may break in the package and in patients during surgical procedures. | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Nee... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histolog... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm O... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | 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.