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.

Clear
DateProductReasonClassFirm
Oct 20, 2021 Artis zee floor with software VD12-angiography systems developed for single a... If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... Class II Siemens Medical Solutions USA, Inc
Oct 20, 2021 Artis Q biplane with software VD12-angiography systems developed for single a... If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... Class II Siemens Medical Solutions USA, Inc
Oct 20, 2021 Artis Q floor with software VD12- angiography systems developed for single an... If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... Class II Siemens Medical Solutions USA, Inc
Oct 20, 2021 Artis Q.zen ceiling with software VD12-angiography systems developed for sing... If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... Class II Siemens Medical Solutions USA, Inc
Oct 14, 2021 SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary by... Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 202... Class III Cardiac Assist, Inc
Oct 12, 2021 Artis icono floor with software VE20C-diagnostic imaging angiography system ... Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... Class II Siemens Medical Solutions USA, Inc
Oct 12, 2021 Artis icono biplane with software VE20C-diagnostic imaging angiography system... Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... Class II Siemens Medical Solutions USA, Inc
Oct 12, 2021 Artis pheno with software VE20C- diagnostic imaging angiography system Mode... Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... Class II Siemens Medical Solutions USA, Inc
Oct 5, 2021 Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10... System operator manual states that the system should be rebooted once, every 7 days. In some case... Class II Siemens Medical Solutions USA, Inc
Oct 4, 2021 THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA Product was released prior to all testing being completed. If used and a drive tube leak were to ... Class II Therakos, Inc.
Sep 24, 2021 Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 i... Software error, the software can produce an incorrect interpretation of the table rotation if the... Class II Siemens Medical Solutions USA, Inc
Sep 21, 2021 ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoline... Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in ... Class II Olympus Corporation of the Americas
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r... Class I Arrow International Inc
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r... Class I Arrow International Inc
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r... Class I Arrow International Inc
Sep 20, 2021 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR ... 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket r... Class I Arrow International Inc
Sep 14, 2021 The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syr... Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist &... Class II Bayer Medical Care, Inc.
Sep 10, 2021 Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ... Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Venti... Class II Draeger Medical, Inc.
Sep 10, 2021 Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for t... Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Venti... Class II Draeger Medical, Inc.
Sep 3, 2021 Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-... Class II Flower Orthopedics Corporation
Sep 1, 2021 Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to... Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class II Flower Orthopedics Corporation
Sep 1, 2021 Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and c... Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class II Flower Orthopedics Corporation
Sep 1, 2021 Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can... Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class II Flower Orthopedics Corporation
Sep 1, 2021 Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and... Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure Class II Flower Orthopedics Corporation
Aug 30, 2021 SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Drive with software syngo.CT VB20 Model #10431700 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Confidence with software syngo.CT VB20 Model #10590100 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Force with software syngo.CT VB20 Model #10742326 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 18, 2021 Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP... Software versions may result in sporadic problems causing scanning workflow interruptions and un... Class II Siemens Medical Solutions USA, Inc
Aug 17, 2021 EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 A gluing step was not performed during the manufacturing of the affected device's insertion tube.... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A... Potential for data loss when using the contouring or patient marking workflow when editing a stru... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2021 BF-P60 OES Bronchofiberscope, Model No. BF-P60 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended... Potential for data loss when using the contouring or patient marking workflow when editing a stru... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2021 syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SO... Potential for data loss when using the contouring or patient marking workflow when editing a stru... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2021 BF-N20 OES Bronchofiberscope, Model No. BF-N20 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-1T60 OES Bronchofiberscope, Model No. BF-1T60 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-3C40 OES Bronchofiberscope, Model No. BF-3C40 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-XP60 OES Bronchofiberscope, Model No. BF-XP60 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 10, 2021 Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for us... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: si... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outloo... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion ... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun 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.