Class IIOngoingZ-1491-2025
Stryker Spine recalls Monterey AL Implant Inserter
Potential for the gold unlock button to separate from the inserter.
Stryker SpineNJApr 9, 2025
Recalls: Device Design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 529–540 of 621 recalls
Class IIOngoingZ-1490-2025
Stryker Spine recalls Monterey AL Implant Inserter
Potential for the gold unlock button to separate from the inserter.
Stryker SpineNJApr 9, 2025
Class IIOngoingZ-1489-2025
Stryker Spine recalls Monterey AL Implant Inserter
Potential for the gold unlock button to separate from the inserter.
Stryker SpineNJApr 9, 2025
Class IIOngoingZ-1488-2025
Stryker Spine recalls Monterey AL Implant Inserter
Potential for the gold unlock button to separate from the inserter.
Stryker SpineNJApr 9, 2025
Class IOngoingZ-1396-2025
Calyxo, Inc. recalls CVAC Aspiration System
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue…
Calyxo, Inc.CAApr 2, 2025
Class IIOngoingZ-1406-2025
American Contract Systems Inc recalls CRANI PACK
During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
American Contract Syst…OHMar 26, 2025
Class IIOngoingZ-1387-2025
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer
Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures.…
Beckman Coulter, Inc.MNMar 26, 2025
Class IIOngoingZ-1325-2025
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
Intuitive Surgical, In…CAMar 19, 2025
Class IIOngoingZ-1294-2025
TAS Medical Inc recalls TISSUE APPROXIMATION SYSTEM (TAS)
Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to i…
TAS Medical IncFLMar 12, 2025
Class IIOngoingZ-1266-2025
Medtronic MiniMed, Inc. recalls MiniMed insulin pump
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane ta…
Medtronic MiniMed, Inc…CAMar 12, 2025
Class IIOngoingZ-1265-2025
Medtronic MiniMed, Inc. recalls MiniMed insulin pump
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane ta…
Medtronic MiniMed, Inc…CAMar 12, 2025
Class IIOngoingZ-1264-2025
Medtronic MiniMed, Inc. recalls MiniMed insulin pump
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane ta…
Medtronic MiniMed, Inc…CAMar 12, 2025