The Recall Desk

Hazard

Labelling Error recalls

21 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
21
Critical
0
Severe
5
Most recent
2026-04-08

Of the 21 labelling error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (24%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all labelling error recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–21 of 21

  • SevereFDA (Drugs)·D-0478-2026·2026-04-08

    Magnesium sulfate pouch recalled as Class I for containing tranexamic acid

    One lot of Magnesium Sulfate in Water for Injection is being recalled after a foil pouch labeled as magnesium sulfate was found to contain an IV bag of tranexamic acid.

    Product
    MAGNESIUM SULFATE — MAGNESIUM SULFATE (MAGNESIUM SULFATE IN WATER FOR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2026·2026-04-08

    Monoject tuberculin syringe packages actually contain U-100 insulin syringes

    Cardinal Health is recalling two lots of Monoject Tuberculin Syringes because the packaging identifies them as 1 mL Luer Lock tuberculin syringes but the contents are U-100 insulin syringes.

    Product
    Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1631-2026·2026-04-01

    BiDop 3 pocket Doppler labeling includes uncleared fetal indication

    Koven Technology is recalling the BiDop 3 Pocket Doppler packaged with a fetal probe because the product labeling includes a fetal indication for use that is not cleared under its 510(k).

    Product
    Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1580-2026·2026-03-25

    Stryker Cub pediatric cribs sold in USA missing two warning labels

    Stryker is recalling Cub Pediatric Cribs, model FL19H, because cribs sold in the USA are missing two access door warning labels.

    Product
    Cub Pediatric Crib, Model FL19H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1574-2026·2026-03-25

    Artegraft vascular graft recalled over incorrect lot outer packaging labeling

    LeMaitre Vascular is recalling one Artegraft Vascular Graft, REF AG740, because of a labeling mix-up resulting in the incorrect lot outer packaging of the product.

    Product
    Artegraft Vascular Graft; REF#: AG740;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1548-2026·2026-03-18

    TRUE METRIX GO manuals recalled as Class I over E-5 error guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX GO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1545-2026·2026-03-18

    TRUE METRIX manuals recalled as Class I over E-5 error code guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1547-2026·2026-03-18

    TRUE METRIX AIR manuals recalled as Class I over E-5 guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX AIR blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1546-2026·2026-03-18

    TRUE METRIX PRO manuals recalled as Class I over E-5 guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX PRO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE MET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1495-2026·2026-03-18

    Zinc paste bandage labeling omitted castor oil and calamine ingredients

    KOB GmbH is recalling Medline Unna-Z Stretch Zinc Paste Bandage because of a labeling error: the ingredients list did not include castor oil or calamine.

    Product
    MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1550-2026·2026-03-18

    Medartis APTUS TriLock screw lots mixed 2.5 mm and 2.8 mm

    Medartis is recalling one lot of the APTUS 2.8 TriLock Screw 16 mm because of a mix up between specified lots of 2.5 mm and 2.8 mm outer diameter screws.

    Product
    Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1549-2026·2026-03-18

    Medartis APTUS 2.5 TriLock screw lots mixed with 2.8 mm

    Medartis is recalling one lot of the APTUS 2.5 TriLock Screw 16 mm because of a mix up between specified lots of 2.5 mm and 2.8 mm outer diameter screws.

    Product
    Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1562-2026·2026-03-18

    Chest drainage unit instructions updated to specify adult patient population

    Medline is recalling three surgical kits containing Cardinal Health Aqua-Seal Chest Drainage Units because the instructions for use have been updated to clarify the target patient population as adults.

    Product
    Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0387-2026·2026-03-11

    Zone 2 lidocaine cream recalled because stability data does not support expiry

    HTO Nevada, trading as Kirkman, is recalling one lot of Maximum Zone 2 4% Lidocaine Cream because the stability data does not support the labeled expiry date.

    Product
    MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1487-2026·2026-03-11

    Datascope CS300 balloon pump manual recalled for outdated battery specifications

    Datascope is recalling the CS300 IABP running software version C.01 because the battery runtime and cycle specifications in the device's Instructions for Use need to be updated.

    Product
    CS300 IABP. Software Version CS300 IABP C.01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1486-2026·2026-03-11

    Datascope CS100 balloon pump manual recalled for outdated battery specifications

    Datascope is recalling the CS100 IABP running software version Q.01 because the battery runtime and cycle specifications in the device's Instructions for Use need to be updated.

    Product
    CS100 IABP. Software Version CS100 IABP Q.01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0385-2026·2026-03-11

    Vasocaine lidocaine spray recalled because stability data does not support expiry

    HTO Nevada, trading as Kirkman, is recalling Five-Star Vasocaine Spray because the stability data does not support the labeled expiry date.

    Product
    FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1493-2026·2026-03-11

    Advanced Bionics sound processor packaging label does not match contents

    Advanced Bionics is recalling two Sky CI M90 Sound Processors because the behind-the-ear sound processor packaging label differs from the product included in the pack.

    Product
    Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1492-2026·2026-03-11

    Vascular grafts recalled after expiry dates were calculated from packaging

    Vascutek is recalling Gelsoft Plus and Gelweave vascular prostheses because they were labeled with an additional month of shelf life, expiry having been calculated from packaging rather than gel impregnation.

    Product
    Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2026·2026-03-11

    Zone 1 lidocaine cream recalled because stability data does not support expiry

    HTO Nevada, trading as Kirkman, is recalling one lot of Maximum Zone 1 4% Lidocaine Cream because the stability data does not support the labeled expiry date.

    Product
    MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0525-2026·2026-03-04

    Packaged cucumber snack recalled for containing undeclared cyclamate sweeteners

    Tengen USA Trading Corp is recalling YO!MAN Cucumber (Fresh Hunan Flavor) because the product contains undeclared cyclamates.

    Product
    YO!MAN CUCUMBER (FRESH HUNAN FLAVOR); Ingredients: Cucumber, chili pepper, edible vegetable oil, salt, water, sugar, brewing vinegar, food additives (monosodium glutamate, sodium dehydroacetate, potassium sorbate, streptoccoccus lactis, sodium D-isoacsorbate, disodium ethylenedia
    Category
    Food
    Distribution
    5 states