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 the agency’s own highest classification or reported deaths or serious injuries, 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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12126–12150 of 39932

  • HighFDA (Devices)·Z-1438-2022·2022-07-27

    BD Connecta White 360 Infusion Connector Recalled for Potential Leakage

    Becton Dickinson recalls BD Connecta White 360 infusion connectors for potential leakage at the stopcock housing. The defect may interrupt treatment and expose patients to biohazardous materials.

    Product
    BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2022·2022-07-27

    Aesculap Sterile Disposable Fleece Drape Recalled Due to Packaging Seal Integrity Issue

    Aesculap recalls 4500 sterile disposable fleece drapes (Product code GA414) due to unvalidated packaging seal integrity, which may compromise sterility assurance. Distribution occurred in 14 U.S. states.

    Product
    Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1391-2022·2022-07-27

    Surgical knee implant instrument key may become nonfunctional during assembly

    Aesculap is recalling the ENDURO SPECIAL KEY TIB.LOCK.RING (product code NP462R) used in knee replacement surgery because the key pins may be damaged during assembly, causing the instrument to become nonfunctional.

    Product
    ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2022·2022-07-27

    Hill-Rom Centrella Pro+ surface mattress microclimate management feature failure

    Baxter Healthcare is recalling Hill-Rom Centrella Pro+ surface mattresses due to a potential Microclimate Management feature failure that may increase the risk of pressure ulcer development.

    Product
    Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2022·2022-07-27

    Sensis Vibe Combo Device Recalled for Software Communication Failure

    The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.

    Product
    Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2022·2022-07-27

    Spinal Fixation Device Removal Key Recalled Due to Potential Fracture Risk

    Aesculap Implant Systems recalls ENNOVATE MIS REMOVALKEY SHORT due to fracture risk if removal key is not used at 90-degree angle. Affected units distributed in CA, CO, IL, MI, OH, and TX.

    Product
    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2022·2022-07-27

    Surgical Coronal Bender May Deform Spinal Implants During Surgery

    Aesculap's coronal rod benders used in spinal surgery may deform implants during use. A Class II recall affects 2 units in Colorado.

    Product
    RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1425-2022·2022-07-27

    Sensis diagnostic tool software may fail to display vital signs

    Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.

    Product
    Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2022·2022-07-27

    BD Connecta Plus3 infusion connector recalled for potential stopcock leakage

    Becton Dickinson is recalling BD Connecta Plus3 White Blend infusion connectors (Lot 1127328) due to potential stopcock leakage. The defect may interrupt treatment, expose patients to biohazardous material, or cause under-infusion.

    Product
    BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1406-2022·2022-07-27

    Spinal Surgery Instrument Recall: LEFT CORONAL BENDER May Deform Implants

    Aesculap Implant Systems LLC is recalling the LEFT CORONAL BENDER (TEK1939) surgical instrument used in spinal procedures because it may deform implants when used with spinal system devices.

    Product
    LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1414-2022·2022-07-27

    Hill-Rom Hospital Mattress Surfaces Recalled for Pressure Ulcer Risk

    Baxter Healthcare is recalling 202 Hill-Rom PRO+ mattress surfaces. The microclimate management feature may malfunction, reducing the product's ability to manage heat and moisture, which increases the risk of patient pressure ulcers.

    Product
    Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1418-2022·2022-07-27

    Genesis II Tibial Baseplate Devices Recalled for Packaging Error

    Smith & Nephew recalled 31 Genesis II Tibial Baseplate devices that were mispackaged with contents not matching the outer box label. This could result in implanting the wrong-sized component during knee surgery.

    Product
    (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2022·2022-07-27

    Ambu VivaSight 2 DLT endobronchial tubes recalled for cuff leak risk

    Ambu Inc. is recalling the VivaSight 2 DLT endobronchial tube system due to reports of cuff leaks or ruptures that could compromise airway security during intubation procedures.

    Product
    Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1410-2022·2022-07-27

    Modulift VBR Surgical Screwdriver Fails Due to Tip Deformation

    Aesculap is recalling the Modulift VBR 4MM set screwdriver due to tip deformation during surgical engagement with implants. The device is distributed in CA, FL, GA, IL, OH, and MI.

    Product
    MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1388-2022·2022-07-27

    Hobbs Medical Polypectomy Snare May Fail to Close Properly

    Hobbs Medical Polypectomy Snares (Catalog No. 7202) may accordion at the proximal end, preventing full closure and potentially causing injury. Specific lots distributed to medical facilities in NC, TX, WA, and Canada are affected.

    Product
    Hobbs Medical Polypectomy Snare, Catalog No. 7202
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1415-2022·2022-07-27

    Medical Bed Mattress Microclimate Failure Increases Pressure Ulcer Risk

    Affected Hill-Rom Centrella Pro+ hospital mattresses can fail to properly manage heat and moisture removal, increasing the risk of pressure ulcer development in patients.

    Product
    Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2022·2022-07-27

    SurgiCount+ System software error bypasses sponge tracking alerts

    A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.

    Product
    SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1408-2022·2022-07-27

    Nonsterile convenience kit recall due to sterile component mislabeling

    ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.

    Product
    Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1424-2022·2022-07-27

    Randox Cholesterol In Vitro Diagnostic Kits Fail Stated Performance Specifications

    Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.

    Product
    Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1409-2022·2022-07-27

    Aesculap Aeos Digital Microscope robotic arm malfunction requires system restart

    Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.

    Product
    Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1386-2022·2022-07-27

    Stryker Trevo Trak 21 Microcatheter recalled for missing carton product illustration

    Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.

    Product
    Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2022·2022-07-27

    Laboratory Reagent Recalled Due to Inaccurate Calibration Curves

    Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.

    Product
    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1423-2022·2022-07-27

    Soluble Transferrin Receptor Calibrator Recall Due to Lab Errors

    Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.

    Product
    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1392-2022·2022-07-27

    GreenLight HPSEA Laser Fiber Recall Due to Card Incompatibility Error

    Boston Scientific is recalling GreenLight HPSEA Laser Fibers due to an incompatibility with the fiber card that causes an error message and requires equipment replacement during procedures.

    Product
    GreenLight HPSEA Laser Fibers, UPN 0010-2092
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1451-2022·2022-07-27

    LumiraDx SARS-CoV-2 Antibody Quality Control Recalled Due to Unauthorized Modification

    LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.

    Product
    LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
    Category
    Medical Device
    Distribution
    13 states