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 |
|---|---|---|---|---|
| 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 |
| Sep 21, 2020 | END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 ... | 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/5 DEG (TI) Product Number: 495.394 ... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 18, 2020 | ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intende... | There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Ph... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 9, 2020 | Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector... | After the March 2019 corrective action on the monitor support arm, there is a residual risk of th... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 9, 2020 | Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector flu... | After the March 2019 corrective action on the monitor support arm, there is a residual risk of th... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, ... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, p... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE ... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE ... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE ... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Sep 8, 2020 | AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, ... | Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... | Class II | Aesculap Implant Systems LLC |
| Aug 31, 2020 | Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to b... | The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associate... | Class II | Olympus Corporation of the Americas |
| Aug 31, 2020 | Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Ol... | The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the d... | Class II | Olympus Corporation of the Americas |
| Aug 19, 2020 | Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_... | Calibration offset between the central CT image plane and the external RT lasers has been set aut... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 3, 2020 | Artis zee or Artis Q systems (listed below) - Product Usage: for single and b... | Potential exists for the collision supervision not to work properly following loss of the individ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 30, 2020 | Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and... | Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 30, 2020 | Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and ... | Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 27, 2020 | Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024 | Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F inst... | Class II | Medical Components, Inc dba MedComp |
| Jul 24, 2020 | Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 modu... | The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connec... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 22, 2020 | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿ | Specific lots of ALTERA¿ implants have internal components that may have been manufactured using ... | Class II | Globus Medical, 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.