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 |
|---|---|---|---|---|
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Num... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now ... | Software error may result in sporadic problems causing scanning workflow interruptions, unexpecte... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 4, 2022 | Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVI... | The product was distributed without FDA authorization or clearance for marketing and distribution... | Class I | SML Distribution, LLC |
| Feb 25, 2022 | syngo Application software VE20 (Material Number 10848815) installed on the ... | After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and ve... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUE... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Artis icono biplane- in combination with a Siemens Healthineers table or Tru... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Artis icono floor in combination with a Siemens Healthineers table or Trumpf... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zeego, Model Number 10280959 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee floor, Model Number 10094135 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q.zen ceiling, Model Number 10848354 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q biplane, Model Number 10848282 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q.zen biplane, Model Number 10848355 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee ceiling, Model Number 10094137 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q floor, Model Number 10848280 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee biplane MN, Model Number 10094143 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee multi-purpose, Model Number 10094139 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee biplane, Model Number 10094141 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q.zen floor, Model Number 10848353 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q zeego, Model Number 10848283 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q ceiling, Model Number 10848281 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee floor MN, Model Number 10094142 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2022 | Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ve... | Cybersecurity Improvement Action-not equipped against potential cyber security threats | Class II | Draeger Medical, Inc. |
| Feb 14, 2022 | Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the vent... | Cybersecurity Improvement Action-not equipped against potential cyber security threats | Class II | Draeger Medical, Inc. |
| Feb 7, 2022 | PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be ... | Units not properly inspected prior to release to the market, may not function as indicated in the... | Class II | B Braun Medical Inc |
| Jan 31, 2022 | Ysiosystem with VC10 software version, Model Number 10281013. Radiographic s... | Siemens Healthineers has identified a software error in previous software version VB10 for the Ys... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 31, 2022 | Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dis... | This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of... | Class II | B. Braun Medical, Inc. |
| Jan 28, 2022 | Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Co... | Firm learned of the potential for cracks to form in the conductivity sensors during use, which ma... | Class II | B Braun Medical Inc |
| Jan 28, 2022 | Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Co... | Firm learned of the potential for cracks to form in the conductivity sensors during use, which ma... | Class II | B Braun Medical Inc |
| Dec 23, 2021 | Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valv... | Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) | Class II | Olympus Corporation of the Americas |
| Dec 22, 2021 | Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135... | Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... | Class I | Philips Respironics, Inc. |
| 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 |
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.