Browse Device Recalls
2,939 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,939 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 2,939 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 22, 2021 | Universal Chuck-The Universal Chuck is an Instrument Handle provided as an al... | Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manu... | Class II | Synthes (USA) Products LLC |
| Dec 22, 2021 | Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The ... | Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... | Class I | Philips Respironics, Inc. |
| Dec 16, 2021 | Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 | 26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxyg... | Class II | Draeger Medical, Inc. |
| Dec 13, 2021 | OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfecti... | The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If th... | Class II | Olympus Corporation of the Americas |
| Dec 9, 2021 | ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray p... | Potential safety issue under specific preconditons that may result in a user selecting the wrong ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2021 | 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, mat... | Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Confidence -Computed tomography systems Model 10590100 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Definition Edge -Computed tomography system Model 10590000 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Definition AS-Computed tomography system Model 8098027 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Edge Plus-Computed tomography system Model 1026700 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 2, 2021 | Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be... | Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter ... | Class II | Flower Orthopedics Corporation |
| Nov 2, 2021 | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V | Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope cont... | Class II | Olympus Corporation of the Americas |
| Oct 25, 2021 | MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium I... | Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation o... | Class II | Aesculap Implant Systems LLC |
| Oct 20, 2021 | Artis zee multi-purpose with software VD12-angiography systems developed for ... | 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 floor with software VD12-angiography systems developed for single... | 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 ceiling 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 zee biplane with software VD12-angiography systems developed for single... | 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 biplane with software VD12- angiography systems developed for sin... | 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 | Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number ... | The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stor... | Class II | Biomeme, Inc. |
| Oct 20, 2021 | Artis zee ceiling with software VD12-angiography systems developed for single... | 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 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 |
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.