The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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Any3+ (High and above)4+ (High and above)5+ (High and above)

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11726–11750 of 13717

  • HighFDA (Devices)·Z-1067-2022·2022-05-18

    Flexible Ureteroscope Recall Due to Inadequate Disinfection Process

    Karl Storz Endoscopy is recalling flexible ureteroscopes manufactured or distributed since January 2018 due to the disinfection process failing to achieve expected microbial reduction levels.

    Product
    11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1049-2022·2022-05-18

    Bronchovideoscope Recall for Updated Sterilization and Reprocessing Instructions

    Olympus bronchovideoscopes are recalled due to updates required for proper sterilization and reprocessing procedures. Healthcare providers must follow new instructions for chemical disinfection and ETO gas sterilization.

    Product
    BF-1TQ180: EVIS EXERA II Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2022·2022-05-18

    Flexible Cystoscopes Recalled for Inadequate Disinfection Process

    Karl Storz Flexible Cystoscope units may not be properly disinfected because the disinfection process fails to achieve the expected reduction of microorganisms. All units manufactured since January 2018 are potentially affected.

    Product
    11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1074-2022·2022-05-18

    Phototherapy Units Recalled for Software Bug Causing Incorrect Dosing

    Daavlin's 4 Series CX phototherapy units are recalled due to a software defect that can cause incorrect dosing (over or under) when resuming interrupted treatments.

    Product
    4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2022·2022-05-18

    KARL STORZ Nasopharyngolaryngoscope Disinfection Failure Affects 14 States

    The FDA is recalling KARL STORZ Slim Nasopharyngolaryngoscope models 11001RD1 and 11001RDK1 because they fail to achieve adequate disinfection, potentially allowing microorganisms to persist on the device and transmit between patients.

    Product
    11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2022·2022-05-18

    Prothrombin Time Reagent Recalled for Quality Control Failures

    Instrumentation Laboratory is recalling HemosIL ReadiPlasTin due to variable and out-of-specification quality control results. The manufacturer is removing all affected lots and providing customers with an alternative reagent.

    Product
    HemosIL ReadiPlasTin, Part No. 0020301400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1048-2022·2022-05-18

    Bronchofibervideoscope Sterilization and Disinfection Procedure Update Recall

    Olympus is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope due to updated instructions required for proper sterilization and reprocessing procedures. Updated guidance for chemical reprocessing, ETO gas sterilization, and disinfection rinsing steps is necessary.

    Product
    BF-MP160F: EVIS EXERA Bronchofibervideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2022·2022-05-18

    Karl Storz Video Ureteroscopes May Not Be Properly Sterilized

    Karl Storz ureteroscopes and flexible video ureteroscopes may fail to achieve adequate sterilization during the disinfection process, potentially leaving microorganisms on the devices that could cause patient infections.

    Product
    11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscop
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1070-2022·2022-05-18

    Flexible video uretero-renoscopes recalled for inadequate sterilization

    Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope (FLEX-XC) models because they may fail to achieve adequate disinfection, creating potential microbial contamination risk.

    Product
    11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK F
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1058-2022·2022-05-18

    ProterixBio SARS-CoV-2 Antibody Test Recalled for Inaccurate Results

    ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test kits are being recalled due to insufficient clinical performance data. The FDA determined test results may not be accurate, with potential false positives or false negatives.

    Product
    ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1037-2022·2022-05-18

    Surgical Device Kits Recalled Due to Improper Sterilization Process

    American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.

    Product
    1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2022·2022-05-18

    VITEK 2 Systems Software Issue May Produce Incorrect Antibiotic Test Results

    bioMerieux VITEK 2 bacterial identification systems have a software defect where antibiotic susceptibility and synergy test results transmitted to laboratory systems may omit user or automated corrections, potentially leading to incorrect test interpretation.

    Product
    VITEK 2 Systems and VITEK 2 with MYLA.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1042-2022·2022-05-18

    Medtronic IN.PACT Admiral balloon catheters recalled for damaged packaging

    Medtronic is recalling IN.PACT Admiral paclitaxel-coated balloon catheters due to damaged packaging that may result in loss of sterility, affecting approximately 6,035 units worldwide.

    Product
    Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P ADM05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2022·2022-05-18

    Karl Storz Flexible Video Urethro Cystoscope Recalled for Inadequate Disinfection

    Karl Storz is recalling multiple Flexible Video Urethro Cystoscope models because they may fail to achieve proper disinfection between procedures, posing a risk of microbial contamination.

    Product
    11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1043-2022·2022-05-18

    Medtronic IN.PACT AV Balloon Catheter: Damaged Packaging May Affect Sterility

    Medtronic is recalling IN.PACT AV paclitaxel-coated balloon catheters because packaging damage may result in loss of sterility. The devices were distributed worldwide and in the United States.

    Product
    Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2022·2022-05-18

    X-ray Imaging Systems Have Reversed Spine Positioning Labels

    Shanghai United Imaging's digital X-ray systems may display reversed spine positioning labels, potentially causing misdiagnosis and unnecessary repeat radiation exposure for patients.

    Product
    Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2022·2022-05-18

    ACS IR Angio Pack Sterilization Process Defect Recall

    The ACS IR Angio Pack from American Contract Systems, Inc. was sterilized using ethylene oxide at higher than specification concentration. No illnesses or injuries have been reported.

    Product
    ACS IR - Angio Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2022·2022-05-18

    Bronchovideoscope Reprocessing Instructions Updated Due to Sterilization Concerns

    Olympus is issuing updated instructions for reprocessing its EVIS EXERA bronchovideoscopes to ensure proper sterilization and disinfection procedures. Improper reprocessing could compromise device safety.

    Product
    BF-3C160: EVIS EXERA Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1063-2022·2022-05-18

    Karl Storz HD Cysto-Urethroscope recalled for disinfection failure

    Karl Storz is recalling HD-VIEW Flexible HD Cysto-Urethroscope models that fail to adequately disinfect during processing, creating a potential infection risk. All units manufactured since January 2018 are affected.

    Product
    11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1065-2022·2022-05-18

    Cysto-Urethroscope Disinfection Process Failure Affects Serial Numbers Since 2018

    Karl Storz Endoscopy is recalling Flexible Video Cysto-Urethroscopes due to a disinfection process failure that may not adequately eliminate microorganisms. Affected units have been distributed nationwide and internationally since January 2018.

    Product
    11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1053-2022·2022-05-18

    Ethicon STRATAFIX Surgical Sutures Recalled for Incorrect Needle Type and Size

    Ethicon is recalling STRATAFIX surgical sutures (lots AAHM529 and AAHQ049) due to component mix-ups resulting in incorrect needle types, sizes, or suture lengths. 2,808 units distributed internationally are affected.

    Product
    STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1073-2022·2022-05-18

    Daavlin 1 Series CX Phototherapy Units Recalled for Software Dosing Error

    Daavlin is recalling 1 Series CX phototherapy units due to a software bug that swaps calibration distance settings when resuming interrupted treatments, resulting in incorrect dosing.

    Product
    1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2022·2022-05-18

    Flexible Uretero-Renoscopes Recalled for Inadequate Disinfection

    Karl Storz Endoscopy is recalling Flexible Video-Uretero-Renoscope instruments due to inadequate microbial disinfection. All units manufactured since January 2018 are affected.

    Product
    11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK F
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1036-2022·2022-05-18

    Spine Surgery Instrument Sets Recalled for Sterilization Defect

    American Contract Systems is recalling ACS Spine Pack and ACS Lumbar/Back Set Up Tray surgical instrument sets due to improper sterilization with excess ethylene oxide. The affected sets were distributed in Illinois, Missouri, Nebraska, and Texas.

    Product
    1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide