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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.