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
Sep 7, 2023 Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software ve... CORI software was missing a planning stage that appears in cases of significant knee deformation ... Class II Blue Belt Technologies, Inc
Sep 1, 2023 (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNE... In some cases, when lubricating grease is present within the headband of the over-ear headphones... Class II Siemens Medical Solutions USA, Inc
Aug 29, 2023 Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to re... Device is breaking while in use, potential for patients to require a revision surgery. Class II Flower Orthopedics Corporation
Aug 25, 2023 Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 4535615444... Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of fun... Class I Philips Respironics, Inc.
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
Aug 7, 2023 B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (... The sterile blister packaging may be damaged, and sterility may be compromised Class II B. Braun Medical, Inc.
Aug 7, 2023 B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deli... The sterile blister packaging may be damaged, and sterility may be compromised Class II B. Braun Medical, Inc.
Jul 31, 2023 Perifix¿ / Epidural anesthesia set, medicated Product may be mislabeled with an incorrect lid stock label. Class II B. Braun Medical, Inc.
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 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

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.