May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Mint Medical GmbH recalls Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Hazard: If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
May 13, 2026Medical DevicesFDA
BioFire Diagnostics, LLC recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Hazard: Contamination to in-vitro diagnostic test may result in false positives.
May 13, 2026Medical DevicesFDA
Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577
Hazard: Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
May 13, 2026Medical DevicesFDA
Erbe Medical, LLC recalls ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Hazard: Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
May 13, 2026Medical DevicesFDA
Erbe Medical, LLC recalls ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fuji
Hazard: Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
May 13, 2026Medical DevicesFDA
Erbe Medical, LLC recalls ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap
Hazard: Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
May 13, 2026Medical DevicesFDA
Spacelabs Healthcare, Inc. recalls Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Softwar
Hazard: Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
May 13, 2026Medical DevicesFDA
Centinel Spine, Inc. recalls Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Hazard: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
May 13, 2026Medical DevicesFDA
Centinel Spine, Inc. recalls Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Hazard: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
May 13, 2026Medical DevicesFDA
Boston Scientific Corporation recalls LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Versio
Hazard: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
May 13, 2026Medical DevicesFDA
Boston Scientific Corporation recalls LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Hazard: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
May 13, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4
Hazard: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
May 13, 2026Medical DevicesFDA
Medical Action Industries, Inc. 306 recalls Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Hazard: Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
May 13, 2026Medical DevicesFDA
American Contract Systems Inc recalls Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Mo
Hazard: Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.
May 13, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Hazard: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
May 13, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
Hazard: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
May 13, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Hazard: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
May 13, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Hazard: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
May 13, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Hazard: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
May 13, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard CATH LAB kit. Model Number: SACL75-01.
Hazard: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
May 13, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard CATH LAB kit. Model Number: SACL75AM.
Hazard: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
May 13, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Hazard: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
May 13, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Hazard: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
May 13, 2026Medical DevicesFDA
AVID Medical, Inc. recalls Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Hazard: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
May 13, 2026Medical DevicesFDA
Ventec Life Systems, Inc. recalls VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Hazard: Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk