Browse Device Recalls

415 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 415 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 415 FDA device recalls.

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DateProductReasonClassFirm
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
May 15, 2023 Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.... 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, 1.8mm OD,... 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) Triple Needle Brus... Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... Class II Olympus Corporation of the Americas
May 4, 2023 Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemosta... Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... Class II Olympus Corporation of the Americas
May 4, 2023 Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemos... Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... Class II Olympus Corporation of the Americas
May 4, 2023 Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemosta... Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... Class II Olympus Corporation of the Americas
May 4, 2023 Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemos... Complaints on clip deployment occurring during clinical procedures, leading to hazardous situatio... Class II Olympus Corporation of the Americas
Apr 18, 2023 Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA II... The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the end... 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.