Browse Device Recalls

2,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,969 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 2,969 FDA device recalls in PA.

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DateProductReasonClassFirm
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 24, 2023 Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring ... Sterility of device may be compromised due to breach of the chevron seal of the packaging Class II Cook Vandergrift, Inc.
Jul 20, 2023 For intraventricular indications mainly used for operations within the brain ... Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a ... Class II Aesculap Implant Systems LLC
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 Carina Sub-Acute Care Ventilator Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed t... Class I Draeger Medical, Inc.
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 30, 2023 LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC ... Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable cu... Class II Cardiac Assist, Inc
Jun 28, 2023 Alcon Custom Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Phaco Standalone Tips Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Infinity FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Constellation Procedure Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Legion FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Centurion FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 19, 2023 ARTIS icono biplane -Angiography systems developed for single and biplane dia... Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... Class II Siemens Medical Solutions USA, Inc
Jun 19, 2023 ARTIS icono floor-Angiography systems developed for single and biplane diagno... Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... Class II Siemens Medical Solutions USA, Inc
Jun 19, 2023 ARTIS pheno-Angiography systems developed for single and biplane diagnostic i... Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... Class II Siemens Medical Solutions USA, Inc
Jun 12, 2023 Oxylog 3000 Plus emergency and transport ventilator Draeger has become aware of instances where the device stopped working when in use when transitio... Class I Draeger Medical, Inc.
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
Jun 5, 2023 Perifix¿ / Epidural anesthesia kit (10 count carton) Kits were assembled with the incorrect Filter Straw. Class II B. Braun Medical, Inc.
Jun 5, 2023 Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operatin... Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potent... Class II Siemens Medical Solutions USA, Inc
Jun 5, 2023 Design Options¿ / Epidural anesthesia kit (10 count carton) Kits were assembled with the incorrect Filter Straw. Class II B. Braun Medical, Inc.
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 25, 2023 Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853)... There are errors present in the Korean Instructions For Use where the word "invasive," was incorr... Class II Philips Respironics, Inc.
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 18, 2023 Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, n... Incorrect product code marked on the product, etched with product code MD611, however; the correc... Class II Aesculap Implant Systems LLC
May 16, 2023 Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s)... The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight va... Class II Draeger Medical Systems, Inc.
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

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.