Class IIOngoingZ-1500-2025
Reichert, Inc. recalls Phoroptor VRx Digital Refraction System Model Numbers: 16241
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Reichert, Inc.NYApr 9, 2025
Recalls: Process control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 673–684 of 816 recalls
Class IIOngoingZ-1467-2025
Checkpoint Surgical Inc recalls Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian…
Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal.…
Checkpoint Surgical In…OHApr 2, 2025
Class IIOngoingZ-1466-2025
Checkpoint Surgical Inc recalls Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian…
Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal.…
Checkpoint Surgical In…OHApr 2, 2025
Class IIOngoingZ-1455-2025
CooperVision, Inc. recalls Brand Names: MyDay Toric
a limited number of lots were manufactured with an incorrect cylinder power.
CooperVision, Inc.NYApr 2, 2025
Class IIOngoingZ-1423-2025
Baxter Healthcare Corporation recalls Baxter NovumIQ Syringe INFUSION SYSTEM
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket.…
Baxter Healthcare Corp…ILApr 2, 2025
Class IIOngoingZ-1408-2025
Premier Dental Products Co recalls Premier Solo Diamond - Large Invented Cone
The hardness not meeting the material specification and may cause the diamond bur to bend.
Premier Dental Product…PAApr 2, 2025
Class IIOngoingZ-1405-2025
Smiths Medical ASD, Inc. recalls CAPNOCHECK BCI Airway Adapter
Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation.…
Smiths Medical ASD, In…MNMar 26, 2025
Class IIOngoingZ-1404-2025
Smiths Medical ASD, Inc. recalls CAPNOCHECK BCI Airway Adapter
Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation.…
Smiths Medical ASD, In…MNMar 26, 2025
Class IIOngoingZ-1397-2025
B Braun Medical Inc recalls Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in.
Increased risk for valve housing detachment causing leakage.
B Braun Medical IncPAMar 26, 2025
Class IIOngoingZ-1391-2025
Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
Product is mislabeled with the incorrect fill volume.
Angiodynamics, Inc.NYMar 26, 2025
Class IIOngoingZ-1371-2025
Microbiologics Inc recalls Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet)
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Microbiologics IncMNMar 26, 2025
Class IIOngoingZ-1362-2025
American Contract Systems Inc recalls VEIN TRAY
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
American Contract Syst…OHMar 26, 2025