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 |
|---|---|---|---|---|
| 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 |
| Jan 5, 2021 | Nucleic acid-based in vitro diagnostic devices for the detection of 2019-nove... | Users cannot complete testing due to a sign-error in the software component that controls the fil... | Class III | Biomeme, Inc. |
| Dec 18, 2020 | ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuar... | CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolu... | Class II | Alung Technologies Inc |
| Dec 18, 2020 | ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 ... | Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or A... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 30, 2020 | Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno | When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 24, 2020 | SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Conf... | System does not trigger a cancel command followed by a reload of the scan with the new parameter(... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2020 | DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgi... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgic... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgica... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgica... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
| Nov 19, 2020 | DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... | Class II | Synthes (USA) Products LLC |
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.