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Browse Device Recalls

2,888 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,888 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 2,888 FDA device recalls in PA.

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DateProductReasonClassFirm
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
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
May 1, 2023 Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN210... Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... Class I Philips Respironics, Inc.
May 1, 2023 Trilogy Evo Universal Ventilator, Model Number DS2000X11B The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventil... Class I Philips Respironics, Inc.
May 1, 2023 Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B,... Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... Class I Philips Respironics, Inc.
May 1, 2023 Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA220... Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... Class I Philips Respironics, Inc.
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
Apr 17, 2023 ID Coax 180, MP03375 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Coax (P) 150, MP00379 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (P) 180 w/oLL, MP00362 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Bag Set (N) 110, MP00383 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax 230, MP03376 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax HEPA, MP17102 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar breathing bag Set (P) 110, MP00384 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (N) 180, MP00353 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax 1, MP02730 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax 180, MP03374 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax 3, MP02732 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (P)250, MP00352 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 ID Circuit Basic (P) 180, MP01340 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax, MP03373 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Anesthesia (N) 180, MP00333 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (P) 180, MP00361 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (N) 180, MP00363 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Set Coax 180, MP03384 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.

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.