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 |
|---|---|---|---|---|
| Jun 9, 2021 | Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, me... | Expired adhesive used as an electrical insulation barrier and as a secondary retention bond faile... | Class II | Olympus Corporation of the Americas |
| May 27, 2021 | ARTIS pheno- angiography systems developed for single and biplane diagnostic ... | Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a ... | Class II | Siemens Medical Solutions USA, Inc |
| May 19, 2021 | Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. int... | Marketed without a 510K | Class II | Arrow International Inc |
| May 19, 2021 | Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-0715... | Marketed without a 510K | Class II | Arrow International Inc |
| May 19, 2021 | Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. intr... | Marketed without a 510K | Class II | Arrow International Inc |
| May 19, 2021 | Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Co... | Marketed without a 510K | Class II | Arrow International Inc |
| Apr 20, 2021 | Multitom RAX with software version VF10 | Siemens identified two issues, In some cases, it is possible to perform an image acquisition alth... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 16, 2021 | PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13 | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medica... | Class II | Aesculap Implant Systems LLC |
| Apr 16, 2021 | PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU | Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medica... | Class II | Aesculap Implant Systems LLC |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Us... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Us... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 15, 2021 | T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) -... | Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending su... | Class II | Flower Orthopedics Corporation |
| Apr 15, 2021 | Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit... | Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the t... | Class II | Vygon U.S.A. |
| Apr 6, 2021 | BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Materi... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Numbe... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Numb... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Mat... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Numb... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Mat... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Mar 30, 2021 | Artis systems - Product Usage: an angiography systems developed for single an... | Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts whic... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 26, 2021 | Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 100... | Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of t... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL482... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL488... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System Tray Sysem knee implant devices as follows: Tray Number/... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL476... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NO180... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL494... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NO156... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 19, 2021 | Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheteriza... | On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. ... | Class II | Cardiac Assist, Inc |
| Mar 19, 2021 | Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTI... | Siemens has become aware of a potential issue with software version VE20C. Planned procedures may... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 19, 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL470... | Malfunction- loosening of the implant resulting in a potential revision surgery | Class II | Aesculap Implant Systems LLC |
| Mar 15, 2021 | Filtered Triple-Leg Extension Set - Intravascular administration set. Product... | BBMI has identified through complaints the potential for the extension set to become occluded or ... | Class II | B. Braun Medical, Inc. |
| Mar 10, 2021 | Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System ... | A patient image was assigned to a different patient during image recovery process. In the unlikel... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 8, 2021 | Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm... | Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the b... | Class II | Arrow International Inc |
| Mar 5, 2021 | Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in ske... | Centinel Spine learned through five customer complaints that the product was missing the "UP" etc... | Class II | Centinel Spine, Inc. |
| Mar 4, 2021 | Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated... | Due to the configuration of certain Windows Service Permissions within the operating systems of... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 3, 2021 | Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed t... | SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 26, 2021 | Interventional Fluoroscopic X-Ray System - Product Usage: developed for singl... | Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 19, 2021 | Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Micro... | Malfunction of the robotic arm preventing further movement of the robotic arm and requiring resta... | Class II | Aesculap Implant Systems LLC |
| Feb 5, 2021 | Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination ... | Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labelin... | Class III | OraSure Technologies, Inc. |
| Jan 29, 2021 | VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Numbe... | Y-piece may become detached from the ventilation hose either before or during the ventilation pro... | Class II | Draeger Medical, Inc. |
| Jan 29, 2021 | VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order... | Y-piece may become detached from the ventilation hose either before or during the ventilation pro... | Class II | Draeger Medical, Inc. |
| Jan 29, 2021 | VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Nu... | Y-piece may become detached from the ventilation hose either before or during the ventilation pro... | Class II | Draeger Medical, Inc. |
| Jan 29, 2021 | ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Numb... | Y-piece may become detached from the ventilation hose either before or during the ventilation pro... | Class II | Draeger Medical, Inc. |
| Jan 28, 2021 | Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Ol... | Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated w... | Class II | Olympus Corporation of the Americas |
| Jan 27, 2021 | Sensis / Sensis Vibe systems with software version VD12 and equipped with HP ... | System may sporadically freeze (lock-up) during operation or while being in an idle state, no lon... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 13, 2021 | Power Injectable CT Port insertion kits - Product Usage: is an implantable ac... | The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F p... | Class II | Medical Components, Inc dba MedComp |
| Jan 6, 2021 | Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the... | The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. Th... | Class II | Arrow International 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.