The Recall Desk

Hazard

Labeling Error recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all labeling 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.

26–50 of 209

  • ModerateFDA (Devices)·Z-2576-2025·2025-09-24

    Frontier Devices 12 mm Distraction Pins Recalled for Unvalidated Shelf Life

    Folsom Metal Products is recalling 3790 units of Frontier Devices 12 mm Distraction Pins due to unvalidated shelf life labeling. Users should contact their healthcare provider for guidance.

    Product
    Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2554-2025·2025-09-17

    Reef TA Inserter may fail to disengage properly during spinal surgery

    SeaSpine Orthopedics is recalling 74 Reef TA Inserters due to potential difficulty disengaging the device during spinal fusion surgery, which may require surgical revision and alternate instrumentation.

    Product
    Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2555-2025·2025-09-17

    Orthofix PILLAR SA Spinal Implant Recalled for Labeling Width Error

    Orthofix recalled the PILLAR SA Ti spinal implant due to labeling errors stating 33mm width instead of the actual 37mm. The discrepancy affects three lots distributed in Colorado and California.

    Product
    PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2392-2025·2025-09-03

    Philips S4-1 Lumify Transducer Probe: Labeling Clarification on Useful Life

    Philips is recalling the S4-1 Lumify Transducer Probe to provide clarification and labeling that defines the useful life of ultrasound transducers. The recall affects 171,322 units distributed nationwide.

    Product
    S4-1 Lumify Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2025·2025-08-20

    Knee implants recalled for incorrect size and side labeling

    Encore Medical is recalling 18 EMPOWR 3D knee implants due to incorrect labeling showing wrong size and/or side. Mislabeled implants could result in the wrong device being used during surgery.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2142-2025·2025-07-30

    Ellik Evacuator Tubing Recalled Due to Sterilization Instruction Discrepancies

    Olympus is recalling tubing for the Ellik Evacuator due to discrepancies between sterilization instructions in Japanese language package inserts and the manufacturer's Instructions for Use.

    Product
    Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2136-2025·2025-07-30

    Medical Device Recall: Non-Sterile Iodine Pouches Mislabeled as Sterile

    CooperSurgical is recalling 991 Endosee System Convenience Kits (Model ES-TRAY) because the iodine pouches are non-sterile but labeled as sterile on the peel-away lid labels. The affected devices were distributed nationwide.

    Product
    Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2025·2025-07-16

    Canturio Smart Extension implant components recalled for labeling error

    Canary Medical is recalling 106 Canturio® Smart Extension knee implant components due to incorrect labeling. Units were distributed in Indiana.

    Product
    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics fo
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·H-0093-2025·2025-07-02

    Dietary supplement recalled for undeclared artificial food colorants

    Protrim Plus dietary supplements contain undeclared artificial colorants (Red No. 40 and Blue No. 1) in the capsules. Consumers should stop using this product and contact the manufacturer.

    Product
    Protrim Plus, dietary supplement. 90 capsule/bottles. Legere Pharmaceuticals 15344 N 83rd way, Scottsdale AZ 85260 (Product does not have a UPC)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2025·2025-06-18

    Greater Trochanter Nail Left-Right Labeling Error Prompts Stryker Recall

    Stryker recalled the T2 Greater Trochanter Nail femoral implant due to labeling errors where affected lots contained opposite-sided nails. The product was distributed in the US, Belgium, Japan, and the Netherlands.

    Product
    Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0931-2025·2025-06-18

    Instant Milk Tea Powder Recall for Undeclared Milk Allergen

    R&M TRADING LLC is recalling Instant Milk Tea Powder (Honeydew Flavor) because the label does not identify milk despite containing whey powder and sodium caseinate. The product poses a risk to milk-allergic consumers.

    Product
    Instant Milk Tea Honeydew Flavor, R&M Refresher brand, B0D7269JC1, net wt. 1lb. Product was sold in 1-pack or 3-pack. Parent ASIN #B0D728CZWS 1-pack ASIN #B0D7269JC1 3-pack ASIN #B0D726K269 Label declares Ingredients: Non-Dairy Creamer (Glucose Syrup, Vegetable Oil, Whey Powd
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0011-2025·2025-06-11

    Instant Oatmeal with Raisins and Spice Recalled for Undeclared Walnut Allergen

    Giant Instant Oatmeal Raisins and Spice is being recalled due to undeclared walnuts on the outer packaging. Consumers with walnut allergies should not consume this product.

    Product
    Giant, Instant Oatmeal Raisins and Spice, 10 -1.5 oz. Packets, per box. Net. Wt. 15.01 oz.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1891-2025·2025-06-11

    FoundationOne Companion Diagnostic Recalled for Incorrect Negative Claim Display

    Foundation Medicine is recalling the FoundationOne Companion Diagnostic (F1CDx) due to an incorrect negative claim displayed on the claims page. The actual test results in the approved report were correct.

    Product
    FoundationOne Companion Diagnostic (F1CDx)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0009-2025·2025-06-11

    Best Taste Brand Salted Shrimp Paste Sauce Contains Undeclared Dye

    Best Taste Brand Salted Shrimp Paste Sauce contains undeclared FD&C Red #3. The product was distributed across multiple US states and should not be consumed.

    Product
    Best Taste Brand Salted Shrimp Paste Sauce; ING: Shrimp, sugar, salt; COUNTRY FAVOR, INC; PRODUCT OF VIETNAM; Net Weight: 12 oz (350 g)
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1863-2025·2025-06-04

    Dental Implant Size Labeling Error Discovered in GM Helix Acqua Units

    Straumann USA is recalling GM Helix Acqua Implants because some packages labeled as 11.5 mm may contain 13 mm implants instead. This size discrepancy could lead to improper implantation.

    Product
    GM Helix Acqua Implant, Article Number: 140.985
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2025·2025-06-04

    Straumann GM Helix Acqua Implants Recalled for Size Mislabeling

    Straumann USA LLC recalls 300 units of GM Helix Acqua Implants due to packaging labeling errors. Packages labeled as 11.5 mm implants may contain 13 mm implants instead, affecting proper surgical placement.

    Product
    GM Helix Acqua Implant, Article Number: 140.984
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1761-2025·2025-05-21

    Spine Surgery Navigation Adaptor Recalled for Inconvenient Knob Design

    Augmedics is recalling the Perc Pin Adaptor component of spine surgery guidance systems due to an inconvenient tightening knob and improperly placed markings.

    Product
    Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2025·2025-05-14

    Artix MT Thrombectomy Device Labeled With Incorrect Vessel Range

    Inari Medical is recalling the Artix MT Thrombectomy Device (45 units) because the label specifies an incorrect vessel diameter range. Using the device outside the correct range could damage blood vessels.

    Product
    Artix MT Thrombectomy Device, REF: 32-102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1718-2025·2025-05-14

    Bio 1 Bone Granules Recalled for Potentially Underfilled Vials

    SCIENCE & BIO MATERIALS is recalling Bio 1 Granules for Filling due to vials that may contain less product than stated on labeling. The recall affects 30 vials distributed nationwide.

    Product
    Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1658-2025·2025-04-30

    Edge Biologicals Sterile Water Recalled for Incorrect Outer Packaging Label

    Edge Biologicals is recalling Sterile Water, 3mL units due to incorrect labeling on the product's outer packaging. No illnesses or injuries have been reported.

    Product
    Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0715-2025·2025-04-23

    Tortilla Chips Recalled for Undeclared Yellow #5 Color Additive

    La Mexicana Tortilla Chips are being recalled due to undeclared Yellow #5, a color additive that must be labeled. The voluntary recall affects 3 boxes distributed in Texas.

    Product
    Tortilla Chip Green 4 cut packed 5lbs per bag; 6 bags per box
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1510-2025·2025-04-09

    Cordis Smart Control Vascular Stent Size Mismatch Recalled

    Cordis recalled 20 units of its Smart Control Vascular Stent System ILIAC due to a labeling mix-up where the external label does not match the actual stent size. Wrong-sized stents could cause serious vessel complications if implanted.

    Product
    Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1503-2025·2025-04-09

    Laboratory diagnostic reagent distributed with incorrect calibration value on package label

    Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D reagent (1,699 units) due to an incorrect International Sensitivity Index (ISI) value printed on the box. No illnesses or injuries have been reported.

    Product
    Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0671-2025·2025-04-02

    Dietary Supplement Recalled for Iodine Content Exceeding Label Claims

    Veridance Pharmacal is recalling 450 bottles of Omni-Macs McDonagh Medical Center Dietary Supplement because iodine levels exceed what is claimed on the label. One customer in Gladstone, Missouri received the affected product.

    Product
    Omni-Macs McDonagh Medical Center Dietary Supplement 100 CAPSULES, Suggested Use: 1-3 capsules per day with meals, Distributed by: McDonagh Medical Center Gladstone, MO 64119
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1274-2025·2025-03-12

    Hiossen Dental Abutments Misidentified on Patient Chart Stickers

    Hiossen is recalling patient chart stickers for dental abutments that incorrectly identify product versions. Stickers mislabel ET Rigid Abutments as Regular and ET Multi Abutments as Mini. Dentists should verify actual product versions against packaging labels.

    Product
    Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
    Category
    Medical Device
    Distribution
    Distributed nationwide