The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

11951–11975 of 22152

  • HighFDA (Devices)·Z-1453-2024·2024-04-10

    Medline Swabsticks PVP Product Recalled for Weak Seal Risk

    Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.

    Product
    MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2024·2024-04-10

    Skull Anchor Key Defect Prevents CT Localizer Attachment

    Navinetics Inc. has recalled the NaviNetics Skull Anchor Key and Drill Kit (Lot 331401724) because the skull anchor key may fail to allow proper attachment of the CT localizer, preventing stereotactic imaging procedures.

    Product
    NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2024·2024-04-10

    Centurion Hemostat Kits Recalled Due to Weak Seal Sterility Breach Risk

    Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.

    Product
    Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2024·2024-04-10

    Exactech Equinoxe Shoulder Glenoid Components Recalled for Defective Packaging

    Exactech is recalling 985 shoulder implant components due to nonconforming packaging that lacks a required oxygen barrier layer. The vacuum bags do not meet packaging specifications.

    Product
    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 he
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1415-2024·2024-04-10

    Exactech Shoulder Implant Components Recalled for Inadequate Oxygen Barrier Packaging

    Exactech Equinoxe shoulder implant components (4,007 units) are recalled because their vacuum-sealed packaging lacks a required oxygen barrier layer, potentially allowing material degradation.

    Product
    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Ext
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2024·2024-04-10

    Centurion Manual Uterine Dilator Surgical Kits Recalled for Weak Seal

    MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.

    Product
    Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2024·2024-04-10

    Centurion Manual Surgical Kits Recalled Due to Weak Seal

    Medline Industries is recalling Centurion manual surgical kits due to weak seals that may compromise sterility. Approximately 7,950 units were distributed nationwide and internationally.

    Product
    Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Implants Recalled for Nonconforming Packaging

    Exactech is recalling 826 Equinoxe Reverse Shoulder humeral liners (Item Numbers 320-36-10 and 320-36-13) due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

    Product
    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1416-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Packaging Defect

    Exactech humeral liners used in shoulder replacement are recalled because the vacuum packaging lacks a required oxygen barrier layer (EVOH), violating established packaging specifications.

    Product
    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0431-2024·2024-04-10

    Lactated Ringers IV Solution Recall: Potential Sterility Failure Risk from Bag Leakage

    B. Braun Medical Inc. is recalling approximately 7,800 bags of Lactated Ringers IV solution (Lot J3N023, exp. March 31, 2026) distributed nationwide due to potential leakage that could compromise sterility.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V745000·2024-04-10

    Honda Recalls 2023 CR-V Hybrid for Battery Module Defect

    Honda is recalling certain 2023 CR-V Hybrid vehicles due to incorrectly manufactured high-voltage battery modules that may break and spark, creating risks of fire and loss of drive power.

    Product
    HONDA — 2023 HONDA CR-V HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2024·2024-04-10

    X-Guide Handpiece Adaptor Sleeve defect affects fit on dental handpiece

    The X-Guide Handpiece Adaptor Sleeve 1 may have a manufacturing defect causing incorrect geometry that prevents proper fit on dental handpieces. Approximately 88 units are affected.

    Product
    X-Guide Handpiece Adaptor Sleeve 1, Model P010701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2024·2024-04-10

    Coloplast Ureteral Dilators Recalled Due to Sterile Packaging Issue

    Coloplast Manufacturing is recalling 710 ureteral dilators due to a possible breach in sterile packaging detected during facility testing. The devices are distributed across multiple US states.

    Product
    Ureteral dilator, REF RBD014
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1446-2024·2024-04-10

    Sterile Rubber Band Recall for Weak Seal Risk

    Medline Industries, LP is recalling Centurion STERILE #16 rubber bands because the package seal may be weak, potentially compromising product sterility. The defect may not be visible to users before opening.

    Product
    Centurion STERILE #16 RUBBER BAND, Product Code EB16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2024·2024-04-10

    Laryngeal Mirror Weak Seal May Breach Sterility

    Medline is recalling Centurion STERILE #5 Laryngeal Mirrors due to weak packaging seals that may not be detectable by users. The defect could result in a breach of the product's sterility if the seal fails.

    Product
    Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2024·2024-04-10

    Exactech Equinoxe shoulder components recalled for nonconforming packaging

    Exactech is recalling 2,008 Equinoxe shoulder implant components due to packaging that lacks a required oxygen barrier layer. The defect does not meet product specifications.

    Product
    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V651000·2024-04-09

    2021-2024 Volkswagen ID.4 Door Handles May Fail Due to Water Ingress

    Volkswagen is recalling 2021-2024 ID.4 vehicles because door handles may allow water to enter the circuit board, causing doors to open unexpectedly while driving. Owners should contact Volkswagen dealers for free inspection and repair.

    Product
    VOLKSWAGEN — 2021 VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V584000·2024-04-08

    BMW vehicles with defective seat belt warning software recalled

    BMW is recalling 2019-2022 330i, M340i, and other models due to receiver audio module software that may fail to generate proper seat belt warnings, increasing crash injury risk.

    Product
    BMW — 2021 BMW 430I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V583000·2024-04-08

    Triumph Tiger Sport 660 Motorcycles Recalled for Engine Stall Risk

    Triumph is recalling 2022-2024 Tiger Sport 660 and Trident 660 motorcycles because the MAP hose may become obstructed, causing incorrect engine readings, stalling, and crash risk. Dealers will replace the hose for free.

    Product
    TRIUMPH — 2024 TRIUMPH TIGER SPORT 660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V546000·2024-04-07

    International LoneStar and LT Battery Cable Defect Poses Stall and Burn Risks

    Navistar is recalling 2018–2021 International LoneStar and 2016–2021 LT vehicles due to defective battery cables that may overheat and cause personal injury or engine stall without warning, increasing crash risk.

    Product
    INTERNATIONAL — 2018 INTERNATIONAL LONESTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V547000·2024-04-07

    Commercial trucks recalled for faulty steering gear assemblies

    PACCAR Incorporated is recalling certain 2022–2023 Peterbilt and Kenworth commercial trucks due to incorrectly assembled steering gears that may fracture. A fractured steering gear can cause loss of steering control, increasing crash risk.

    Product
    PETERBILT — 2022 PETERBILT 536
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V544000·2024-04-07

    2021-2022 Jeep Grand Cherokee Tail Light Side Marker Assembly Replacement

    Chrysler is recalling certain 2022 Jeep Grand Cherokee and 2021-2022 Jeep Grand Cherokee L vehicles due to damaged tail light side marker assemblies that may not illuminate, reducing visibility and increasing crash risk.

    Product
    JEEP — 2021 JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V545000·2024-04-07

    2022 Winnebago Voyage Travel Trailer Awning Separation Hazard

    Winnebago is recalling certain 2022 Voyage travel trailers because the awning's welded seam may separate, causing it to drop and increase injury risk.

    Product
    WINNEBAGO — 2022 WINNEBAGO VOYAGE!
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V402000·2024-04-06

    Steering Tie Rod Defect Recall: 2025 Freightliner, Western Star, and FCCC Trucks

    Daimler Trucks North America is recalling 2025 Freightliner, Western Star, and FCCC commercial trucks because the front axle tie rod ball joint studs may crack, causing tie rod separation and sudden loss of steering control.

    Product
    FCCC — 2025 FCCC S2C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V395000·2024-04-06

    Forest River Puma and Cedar Creek trailers recalled for fire risk

    Forest River is recalling 2004-2024 Cedar Creek and 2006-2024 Puma fifth-wheel trailers due to potentially loose wires in the battery electrical system that could cause fires.

    Product
    FOREST RIVER — 2007 FOREST RIVER PUMA
    Category
    Vehicle
    Distribution
    Distributed nationwide