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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
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.
Apr 17, 2023 VentStar Anesthesia WT (P)180, MP00374 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Seattle PAP Plus, MP02260 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Set2Go Ventilation 12 (A), MP07968 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)180, MP00351 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 6, 2023 ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intende... Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.... Class II Hiossen Inc.
Mar 31, 2023 To be used with ultrasound endoscopes for ultrasound guided fine needle aspir... Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifi... Class III Olympus Corporation of the Americas
Mar 31, 2023 ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endo... Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifi... Class III Olympus Corporation of the Americas
Mar 27, 2023 Omnicell IVX Station-For use in the automated preparation of pharmaceutical a... IVX Station does not account for inherent scale inaccuracy or variability, could result in a prep... Class II OmniCell, Inc.
Mar 21, 2023 Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagul... Potential for the spring to become loose and fall out of the device, if the spring falls out duri... Class II Aesculap Implant Systems LLC
Mar 21, 2023 ARTIS one with a hybrid cable- An angiography system developed for diagnostic... Examination room monitor connected with the hybrid cable may have a display issue and no image fu... Class II Siemens Medical Solutions USA, Inc
Mar 9, 2023 DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1... The instruction manual is being replaced with an updated version that is in alignment with labeli... Class II DeVilbiss Healthcare LLC
Mar 1, 2023 Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers D... The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... Class I Philips Respironics, Inc.
Mar 1, 2023 Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... Class I Philips Respironics, Inc.
Mar 1, 2023 Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X... The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... Class I Philips Respironics, Inc.
Feb 24, 2023 Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device us... Problem maintaining the stable placement of the battery may come loose from the housing and beco... Class II Tobii Dynavox Llc
Feb 23, 2023 Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cer... Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955... Class II Aesculap Implant Systems LLC
Feb 23, 2023 Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 16... There have been complaints that the clip did not come out of the tube sheath during the procedure. Class II Olympus Corporation of the Americas
Feb 20, 2023 Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-ter... Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolong... Class II Moberg Research, Inc.
Feb 10, 2023 Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S... A limited number of remediated Philips DreamStation units may experience communication issues whe... Class I Philips Respironics, 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.