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.

Clear
DateProductReasonClassFirm
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.