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Consumer Product Recalls
127,244 recalls from the U.S. Consumer Product Safety Commission, newest first.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step K in vitro diagnostic test REF: 81A4
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls Uric Acid in vitro diagnostic test REF: 31H0P
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step pH in vitro diagnostic test REF: 31I4P
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step UTI in vitro diagnostic test REF: 3374
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step 10A in vitro diagnostic test
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Hazard: Respiratory/sore throat panel test may result in false negative results and control failures.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Hazard: Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-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 Super Grip Forceps, Model/Catalog Number: DVF4034-25
Hazard: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Medical DevicesFDA
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-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, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
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 Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-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 Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
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 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.