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 |
|---|---|---|---|---|
| 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 |
| Nov 19, 2020 | DePuy Synthes 11.5MM 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 12.0MM 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 18, 2020 | ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R | Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle... | Class II | Aesculap Implant Systems LLC |
| Oct 23, 2020 | The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnost... | The firm has become aware of nine reports by a single customer that the software made false posit... | Class II | Biomeme, Inc. |
| Oct 21, 2020 | Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluo... | Some electronic components within the generator were equipped with an incorrect protection diode.... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 16, 2020 | Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used fo... | A new inspection step was added to the cleaning and disinfection section of the Instructions For ... | Class II | Olympus Corporation of the Americas |
| Oct 16, 2020 | Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: us... | A new inspection step was added to the cleaning and disinfection section of the Instructions For ... | Class II | Olympus Corporation of the Americas |
| Oct 16, 2020 | Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used wi... | A new inspection step was added to the cleaning and disinfection section of the Instructions For ... | Class II | Olympus Corporation of the Americas |
| Oct 16, 2020 | Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: us... | A new inspection step was added to the cleaning and disinfection section of the Instructions For ... | Class II | Olympus Corporation of the Americas |
| Oct 16, 2020 | Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used w... | A new inspection step was added to the cleaning and disinfection section of the Instructions For ... | Class II | Olympus Corporation of the Americas |
| Oct 16, 2020 | Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used w... | A new inspection step was added to the cleaning and disinfection section of the Instructions For ... | Class II | Olympus Corporation of the Americas |
| Oct 16, 2020 | Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used wit... | A new inspection step was added to the cleaning and disinfection section of the Instructions For ... | Class II | Olympus Corporation of the Americas |
| Oct 16, 2020 | Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: use... | A new inspection step was added to the cleaning and disinfection section of the Instructions For ... | Class II | Olympus Corporation of the Americas |
| Oct 16, 2020 | Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: us... | A new inspection step was added to the cleaning and disinfection section of the Instructions For ... | Class II | Olympus Corporation of the Americas |
| Oct 16, 2020 | Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: u... | A new inspection step was added to the cleaning and disinfection section of the Instructions For ... | Class II | Olympus Corporation of the Americas |
| Oct 5, 2020 | Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Sy... | Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have... | Class II | Bayer Medical Care, Inc. |
| Sep 21, 2020 | DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Pr... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 ... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 ... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray ... | Potential malfunction in which the examination room monitor may become intermittently dysfunction... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 21, 2020 | END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a v... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usag... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a v... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: ... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: ... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usag... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a v... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a ... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usa... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | 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.