Hazard

Mis Labeling recalls

9,622 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 9,622
Critical: 163
Severe: 590
Most recent: 2026-09-24

Of the 9,622 mis labeling recalls we have scored against our rubric, 163 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 590 (6%) 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 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.

9301–9325 of 9622

ModerateFDA (Devices)·Z-2457-2012·2012-10-03
Integra Limited Recalls Mispackaged MAYFIELD Horseshoe Gel Pads
Integra Limited is recalling 11 MAYFIELD Horseshoe Gel Pads from Lot 0938990 because left and right pads were incorrectly packaged. No patient injuries were reported.
Product
The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The G
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1691-2012·2012-10-03
Dispensing Solutions Recalls Atrovent HFA Inhalers Due to Label Error
Dispensing Solutions, Inc. is recalling 18 Atrovent HFA inhalers because a sticker label incorrectly identifies the product as Ventolin HFA.
Product
Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947
Category
Drug
Distribution
2 states
ModerateFDA (Devices)·Z-2471-2012·2012-10-03
Ev3 Neurovascular Recalls Mislabeled UltraFlow Micro Catheters
Ev3 Neurovascular is recalling 36 UltraFlow HPC Flow Directed Micro Catheters because one lot may have been mislabeled.
Product
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolizat
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2442-2012·2012-10-03
Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling
Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because the products are incorrectly labeled.
Product
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2472-2012·2012-10-03
Ev3 Neurovascular Recalls Mislabeled Marathon Flow Directed Micro Catheters
Ev3 Neurovascular is recalling 23 units of Marathon Flow Directed Micro Catheters because one lot may have been mislabeled.
Product
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization mate
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1692-2012·2012-10-03
Mallinckrodt Recalls Thallous Chloride Tl 201 Injection Due to Labeling Mismatch
Mallinckrodt Inc. is recalling specific lots of Thallous Chloride Tl 201 Injection because outer container labels do not match the vial labels.
Product
Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration
Category
Drug
Distribution
11 states
LowFDA (Devices)·Z-2454-2012·2012-10-03
Neomend Recalls Progel Pleural Air Leak Sealant Due to Incorrect Expiration Date
Neomend Inc is recalling 95 units of Progel Pleural Air Leak Sealant because the product was labeled with an incorrect expiration date.
Product
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2445-2012·2012-10-03
Trinity Biotech Captia VZV IgG Kits Recalled for Positive Control Issues
Clark Laboratories is recalling 810 Captia VZV IgG kits because the positive control ran high out of its assigned range.
Product
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·12V471000·2012-09-27
Starcraft Recalls 2012-2013 AR-One Travel Trailers for Inaccurate Load Labels
Starcraft RV is recalling 2012 and 2013 AR-One travel trailers because inaccurate load capacity labels may lead to incorrect tire replacements, increasing crash risk.
Product
STARCRAFT — STARCRAFT AR-ONE
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2356-2012·2012-09-26
Hocean Recalls Nitre Powder Lacking Required Directions for Use
Hocean Inc is recalling Nitre powder because the label lacks required directions for use, which could lead to overuse and life-threatening health hazards.
Product
Nitre powder. Brand "Selected Product", 4oz plastic bags, UPC 0 45027 97918 2.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2360-2012·2012-09-26
Tres Monjitas Pineapple and Guava Beverage Recalled for Undeclared Allergen
Vaqueria Tres Monjitas, Inc. is recalling its Pineapple and Guava Beverage because it contains undeclared sodium caseinate, a milk derivative.
Product
"Tres Monjitas***Pineapple and guava beverage***Distribuido por Vaquer¿a Tres Monjitas Inc***" Package sizes: gallons, 1/2 gallons, quarts, 14 oz and 8 oz.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2387-2012·2012-09-26
Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Testing Errors
Instrumentation Laboratory is recalling ACL TOP analyzers because they may report abnormal fibrinogen levels as normal or vice versa, potentially affecting clinical decisions.
Product
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2403-2012·2012-09-26
Roche Amplilink Software Recall Due to Potential Wrong Test Results
Roche Molecular Systems is recalling Amplilink Software 3.2.3 because it may assign wrong results to orders when used with certain Laboratory Information Systems.
Product
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2388-2012·2012-09-26
Instrumentation Laboratory ACL TOP 700 Recalled for Fibrinogen Test Errors
Instrumentation Laboratory is recalling ACL TOP 700 analyzers because they may report abnormal fibrinogen levels as normal or low levels as high.
Product
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thromb
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2331-2012·2012-09-26
Somersaults Crunchy Nuggets Recalled for Undeclared Milk Allergen
Somersault Snack Co. is recalling Crunchy Nuggets because some packages contained Santa Fe Salsa crackers with undeclared milk protein.
Product
Somersaults Crunchy Nuggets baked with sunflower seed and toasted grains. Pacific Sea Salt Flavor, Net Wt. 6 oz. UPC 8-98403 00201-7;
Category
Food
Distribution
15 states
HighFDA (Devices)·Z-2392-2012·2012-09-26
Instrumentation Laboratory ACL TOP 700 CTS Recalled for Fibrinogen Test Errors
Instrumentation Laboratory is recalling ACL TOP 700 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.
Product
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2328-2012·2012-09-26
Crispy Punjabi Cookies Recalled for Undeclared Milk Allergen
Singh And Singh Distributors Inc. is recalling Crispy Punjabi Cookies because the product contains milk but the label does not declare it as an ingredient.
Product
Crispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada.
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-2398-2012·2012-09-26
Bio-Rad MONOLISA Anti-HBs EIA Recalled Due to Light Exposure Issues
Bio-Rad Laboratories is recalling MONOLISA Anti-HBs EIA kits because light exposure to the Conjugate Diluent may cause false positive or grey zone results.
Product
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Ra
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2348-2012·2012-09-26
R&S Tomato Basil Tortillas Recalled for Undeclared Yellow Dye
R&S Mexican Food Products is recalling Tomato/Basil Pressed Tortillas because they contain undeclared FD&C Yellow #6. The product was distributed to four accounts in Arizona.
Product
R&S Mexican Food Products, Inc. Tomato/Basil Pressed Tortillas, 1 Dozen. Packaged in sealed flexible plastic bag.
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-2413-2012·2012-09-26
FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products
Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to packaging mislabeling where product sizes do not match package labels.
Product
Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2412-2012·2012-09-26
FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products
Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to size mislabeling on the packaging.
Product
Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2414-2012·2012-09-26
DePuy S-ROM Total Hip System Poly Liner Recalled for Labeling Error
DePuy Orthopaedics is voluntarily recalling four lots of S-ROM Total Hip System Poly Liners because the carton labels contain an incorrect color code series designation.
Product
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a f
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2397-2012·2012-09-26
BD FACS 7-color Setup Beads Recalled for Incorrect CD Version
BD Biosciences is recalling 96 kits of BD FACS 7-color Setup Beads because the included CD contained the incorrect version.
Product
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, in
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1683-2012·2012-09-26
Apace Recalls Enalapril Maleate Tablets Due to Illegible Labeling
Apace KY LLC is recalling 81,516 bottles of Enalapril Maleate 5mg tablets because some labels have incomplete NDC numbers and missing strength information.
Product
Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2393-2012·2012-09-26
Amsino Medical Recalls Mislabeled 0.9% Sodium Chloride Flush Syringes
Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Flush syringes that may be mislabeled as 10 mL instead of 3 mL.
Product
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Category
Medical Device
Distribution
1 state