The Recall Desk

Hazard

Mis Labeling recalls

9,611 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,611
Critical
161
Severe
589
Most recent
2026-09-24

Of the 9,611 mis labeling recalls we have scored against our rubric, 161 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 589 (6%) are Severe.

About this hazard tag

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

8301–8325 of 9611

  • ModerateFDA (Devices)·Z-0394-2014·2013-12-04

    Synthes Spiked Washers Recalled Due to Mislabeled Size

    Synthes USA HQ, Inc. is recalling Spiked Washers 13.5/6.5 because they were mislabeled as 13.5/5.5 during a retrospective assessment.

    Product
    Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0399-2014·2013-12-04

    Medtronic Recalls Strata II Shunt Kits Due to Label Discrepancies

    Medtronic Neurosurgery is recalling Strata II Shunt Assembly Kits and other CSF shunts because of label discrepancies. The recall affects 5 units distributed worldwide.

    Product
    Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0410-2014·2013-12-04

    Synthes Recalls Vertebroplasty Needle Kits Due to Expiration Date Inconsistencies

    Synthes USA is recalling 40 Vertebroplasty Needle Kits because of inconsistent expiration dates on the packaging.

    Product
    Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0409-2014·2013-12-04

    Synthes 4.5 mm LCP Curved Condylar Plate Recalled for Mislabeling

    Synthes USA HQ, Inc. is recalling 13 units of the 4.5 mm LCP Curved Condylar Plate because straight plates are etched with the curved plate's part number.

    Product
    Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0402-2014·2013-12-04

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX and 100NX sterilizers because bronchoscopes may contain unlisted polyurethane material in the suction channel.

    Product
    STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0397-2014·2013-12-04

    Medtronic Recalls CSF-Unitized Shunts Due to Label Discrepancies

    Medtronic Neurosurgery is recalling CSF-Unitized Shunts, Delta Shunt Assembly Kits, and Strata II Shunt Assembly Kits due to label discrepancies.

    Product
    CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0382-2014·2013-12-04

    Southern Implants Recalls Tri-Nex Healing Abutments Due to Labeling Error

    Southern Implants is recalling 197 Tri-Nex healing abutments because the packages were incorrectly labeled and contained the wrong product size.

    Product
    Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0407-2014·2013-12-04

    Synthes Titanium Humeral Nail Recalled for Incorrect Packaging Labeling

    Synthes USA is recalling 14 Titanium Cannulated Humeral Nails because the packaging incorrectly depicts the device as having 3 distal holes instead of 2.

    Product
    Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0428-2014·2013-12-04

    3M Recalls Unitek Stainless Steel Crowns Due to Mislabeling

    3M is recalling specific lots of Unitek Primary Stainless Steel Crowns because LL3 crowns were incorrectly labeled as UR4 crowns.

    Product
    3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-020-2014·2013-12-04

    Valeant Recalls Acanya Gel Samples Due to Incorrect Expiration Date

    Valeant Pharmaceuticals is recalling 45,000 tubes of Acanya gel physician samples because they were assigned an incorrect expiration date.

    Product
    Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0379-2014·2013-12-04

    Alere Cholestech LDX Lipid Profile-GLU Test Cassettes Recalled for Labeling Error

    Alere San Diego, Inc. is recalling 3,621 kits of Cholestech LDX Lipid Profile-GLU test cassettes because an incorrect lot number was printed on the packaging.

    Product
    Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0182-2014·2013-11-27

    Krispak Recalls Good Sense Spicy Sweet Mix for Undeclared Allergens

    Krispak Inc. is voluntarily recalling one lot of Good Sense Spicy Sweet Mix because it was mislabeled, resulting in undeclared almond and cashew allergens.

    Product
    Good Sense Spicy Sweet Mix, 25-oz (1lb 9oz) plastic container, UPC: 030243787178
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0222-2014·2013-11-27

    CTF Brand Tapioca Pearl Pandan Recalled for Missing Ingredient Labeling

    N A Trading Inc is recalling CTF Brand Tapioca Pearl Pandan because the packaging fails to list Artificial Color Yellow No. 5 and Brilliant Blue FD&C No. 1.

    Product
    CTF Brand Tapioca Pearl Pandan (Green Color), 14oz Plastic Bags, Packaged at 50 bags per case. Packaged in plastic heat-sealed pouch. Brand name is CTF with an illustration of a deer. Product labeling reads in part:"C.T.F. Brand TAPIOCA PEARL***EXPORTED: COMBINE THAI FOODS
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0220-2014·2013-11-27

    Swanson Black Cumin Seed Capsules Recalled for Mislabeling

    Swanson Health Products is recalling two lots of Black Cumin Seed capsules because they contain White Cumin Seed instead.

    Product
    Swanson, Premium Brand, Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules, 400 mg, SW1361, UPS 0 87614 11361 6.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0336-2014·2013-11-27

    Terumo Recalls Mislabelled Vascutek Gelsoft Vascular Grafts

    Terumo CVS is recalling nine Vascutek Gelsoft vascular grafts because they were incorrectly labeled with the wrong diameter.

    Product
    Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inc
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0366-2014·2013-11-27

    Teleflex Medical Recalls Green Rusch Laryngoscope Blades for Labeling Inconsistency

    Teleflex Medical is recalling 6,200 Green Rusch laryngoscope blades due to a labeling inconsistency. The devices were distributed nationwide.

    Product
    Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-005-2014·2013-11-27

    L. Perrigo Recalls Infants' Pain and Fever Due to Unmarked Syringes

    L. Perrigo Co. is recalling 27,504 bottles of TopCare Infants' Pain and Fever because some cartons may contain dosing syringes without dose markings.

    Product
    TOPCARE INFANTS PAIN AND FEVER — TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0347-2014·2013-11-27

    Riverpoint Recalls Vilet Surgical Suture Due to Labeling Error

    Riverpoint Medical is recalling 1,932 pieces of Vilet surgical suture because the label incorrectly states the suture is undyed when it is actually violet.

    Product
    Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalm
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0219-2014·2013-11-27

    Best in Nature Eye Care Essence Recalled for Missing Ingredients

    Diamond Nutriceutical, Inc. is recalling Best in Nature Eye Care Essence because FDA testing found the product lacked labeled amounts of Vitamin A and Vitamin C.

    Product
    Best in Nature Brand Eye Care Essence, 100 Capsules. Product labeling reads in part:"Best in Nature Eye Care Essence***Dietary Supplement 100 capsules***Manufactured for: Best in Nature Walnut, CA 91789***www.1688best.com***8 92418 001069 6***".
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0365-2014·2013-11-27

    Siemens Chemistry Calibrator Recall for Direct Bilirubin Assay Shift

    Siemens is recalling Chemistry Calibrators for the Direct Bilirubin Assay because reassigned System Specific Values may cause an average shift in results.

    Product
    Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of dir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V593000·2013-11-25

    Peterbilt Trucks Recalled for Missing Certification Label Information

    PACCAR is recalling 2004-2013 Peterbilt trucks because missing certification label information may lead to axle overloading or improper tire installation, increasing crash risk.

    Product
    PETERBILT — PETERBILT 385, 389, 386, 388
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0170-2014·2013-11-20

    Oh Bok Bakery Recalls Sweet Bread for Undeclared Wheat Flour

    Cho & So, Inc. DBA Oh Bok Bakery is recalling ASSI brand Sweet Bread (Bam Bbang) because wheat flour was not declared on the label.

    Product
    Sweet Bread known as Bam Bbang (Chestnut Bread) packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20646D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0169-2014·2013-11-20

    Oh Bok Bakery Recalls Doughnuts for Undeclared Wheat Allergen

    Cho & So, Inc. DBA Oh Bok Bakery is recalling ASSI brand Korean Cake doughnuts because wheat flour was not declared on the label.

    Product
    Doughnuts packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20645D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling
    Category
    Food
    Distribution
    0 states