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.

126–150 of 209

HighFDA (Devices)·Z-2135-2023·2023-07-19
Medline Non-Sterile PVP Solution Incorrectly Labeled as Sterile
Medline is recalling Non-Sterile PVP Solution Hystero Pack kits due to mislabeling: affected lots labeled as 'Sterile' when actually 'Non-Sterile'. Using non-sterile solution in sterile gynecological procedures creates infection risk.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2093-2023·2023-07-12
COVID-19 Test Strips Recalled for Lot Number Label Discrepancy
NeuMoDx SARS-CoV-2 test strips from lot 123909 have conflicting lot numbers between the package label and barcode label that the instrument reads.
Product
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). RE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2019-2023·2023-07-05
Orthopedic Assembly Screws Recalled Due to Labeling and Size Swap Error
Tornier recalled 55 AEQUALIS FLEX REVIVE Assembly Screws (Model ARS655101) due to a labeling swap where Standard-length units were marked Short, and vice versa. This could result in implantation of the wrong screw size during orthopedic surgery.
Product
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1973-2023·2023-06-21
Total Knee Pack Medical Kits Recalled for Incorrect Expiration Date
American Contract Systems is recalling 36 Total Knee Pack medical convenience kits distributed to Massachusetts due to an incorrect expiration date on the product labeling.
Product
Total Knee Pack, REF CETJ130, medical convenience kits
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1907-2023·2023-06-21
Cardiosave Hybrid IABP Recall: Incorrect Compliance Annotation in Instructions
The Cardiosave Hybrid Intra-Aortic Balloon Pump software update version D.00 includes instructions with incorrect annotations about compliance to standard 60601-1-12:2014. Four units were distributed in Germany.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0770-2023·2023-05-31
Fentanyl buccal tablets recalled due to incorrect or missing package insert
Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets 800mcg due to incorrect or missing package inserts. The recall affects 3,032 units distributed nationwide.
Product
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0888-2023·2023-05-24
Wakame Seaweed Salad recalled for undeclared wheat allergen
Origami Catering's Wakame Seaweed Salad is recalled because wheat is present but not declared in the allergen statement. Affected product: 4.5oz packages, UPC 8 51016 00235 5, distributed in Oregon and Washington.
Product
Wakame Seaweed Salad, ready to eat product. Net Weight: 4.5oz 127g. UPC 8 51016 00235 5. Label Ingredients declares: Seaweed (Wakame), Agar Agar ***, Sesame Seeds, Sesame Oil,***Soy Sauce ( Soy, Wheat***)*** Contains Soy, Sesame***". UPC: 8 51016 00235 5. Manufactured by Origam
Category
Food
Distribution
0 states
LowFDA (Food)·F-0864-2023·2023-05-17
Nitto Foods Immediately Pickled Dashi Recalled for Fish Labeling Issue
Nitto Foods Immediately Pickled Dashi (5.5g x 2 bags, UPC 4902362032100) is being recalled due to labeling inconsistencies related to fish ingredients. The product was distributed across multiple US states and British Columbia.
Product
Nitto Foods Immediately Pickled Dashi 5.5g x 2 Bags UPC: 4902362032100
Category
Food
Distribution
0 states
HighFDA (Food)·F-0804-2023·2023-05-10
Blue Moon Bakery Ginger Molasses Cookie Sesame Allergen Recall
Bakery 37 Inc recalls Blue Moon Bakery Ginger Molasses Breakfast Cookies (3oz) distributed in Oregon due to sesame declared in ingredients but not in the allergen Contains statement. Affected manufacturing dates: January 1 to March 22, 2023.
Product
Blue Moon Bakery Ginger Molasses Breakfast Cookie identified as a 3oz (84g) cookie with fresh ginger and crystallized ginger chunks is frozen, packed in a clear sealed bag. UPC 852240004030. Sesame seeds is identified in the ingredients statement. Advisory statement reads "Contai
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-0532-2023·2023-04-19
Prescription Drug Recall: Incorrect Expiration Date on MEKTOVI Labels
Pfizer recalls 1,926 bottles of MEKTOVI (binimetinib) due to incorrect expiration dates on labels. Bottles labeled March 2026 actually expire February 2025.
Product
MEKTOVI — MEKTOVI (BINIMETINIB)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1320-2023·2023-04-12
Biosense Webster guiding sheath recalled for labeling mismatch
Biosense Webster is recalling 316 units of Carto Vizigo guiding sheaths because the carton label does not match the inner sterile pouch label, potentially affecting product identification.
Product
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1319-2023·2023-04-12
Biosense Webster Guiding Sheath Recalled for Carton Label Mismatch
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheaths are being recalled because the carton label does not match the inner pouch label. No illnesses or injuries have been reported.
Product
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1248-2023·2023-03-22
TFN Femoral Nails dimensions mislabeled, may measure 170mm or 200mm
Synthes recalled TFN-Advanced Femoral Nails because some units have incorrect dimensions: nails labeled 200mm may measure 170mm, while those labeled 170mm may measure 200mm. This dimensional mismatch could compromise surgical fixation.
Product
TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1187-2023·2023-03-08
EMPOWR VVC Knee Tibial Insert Recalled for Reversed Box Labeling
Encore Medical recalls EMPOWR VVC Knee Tibial Inserts due to reversed box labeling—large inserts marked as small and vice versa. Surgeons may implant the wrong size if the labeling discrepancy is not identified before surgery.
Product
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709; EMPOWR VVC KNEE TIBIAL INSERT, S
Category
Medical Device
Distribution
5 states
SevereFDA (Drugs)·D-0131-2023·2023-01-25
Daptomycin for Injection Recalled Due to Incorrect Labeling Dosage
Accord Healthcare is recalling Daptomycin for Injection labeled as 350 mg/vial but containing 500 mg/vial vials. The labeling error poses a dosing risk to patients.
Product
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0458-2023·2022-12-14
Propel Mini Sinus Implant Recalled for Incorrect Product Label Information
Intersect ENT is recalling 611 units of Propel Mini Mometasone Furoate Sinus Implant due to incorrect product identification information on the label. The label displays wrong reference numbers and UDI-DI codes.
Product
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0341-2023·2022-12-07
BCL11B Diagnostic Reagent Recalled for Chromomap Documentation Error
Cytocell Ltd. is recalling a diagnostic reagent due to an error in the chromomap on the package insert. The nucleotide locations in the text are correct, but the chromosome map was created using incorrect coordinates.
Product
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0183-2023·2022-11-16
Zio AT Ambulatory ECG Monitoring System Documentation Labeling Update
iRhythm Technologies is recalling clinical reference materials for the Zio AT cardiac monitoring system due to labeling deficiencies that may delay notification of arrhythmias to healthcare providers. Transmission limits could prevent critical cardiac event reporting.
Product
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
Category
Medical Device
Distribution
48 states
ModerateFDA (Devices)·Z-0181-2023·2022-11-16
Dialysis concentrate labeling error for chemical composition
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate (dialysis product) due to incorrect labeling. The label misidentifies 5.62g/L as potassium chloride when it actually represents calcium chloride, though the product itself is potassium-free.
Product
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Category
Medical Device
Distribution
21 states
SevereFDA (Drugs)·D-0019-2023·2022-11-02
Atenolol 25mg bottles mislabeled; contain Clopidogrel 75mg tablets
Golden State Medical Supply Inc. is recalling 2,584 bottles of Atenolol 25mg tablets nationwide. Bottles labeled as Atenolol 25mg actually contain Clopidogrel 75mg tablets—a different medication.
Product
ATENOLOL — ATENOLOL (ATENOLOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0122-2023·2022-11-02
Medline Blood Culture Kits recalled due to mismatched component expiration dates
Medline Industries is recalling 1,600 blood culture kits (Reorder # DYNDH1592) because component expiration dates don't match the kit label. Affected components include CHG Solution and Bactec bottle plastic.
Product
MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0123-2023·2022-11-02
Blood Culture Collection Kit Distributed with Mismatched Component Expiration Dates
Medline is recalling 760 blood culture kits because the expiration dates printed on the kit do not match the expiration dates on the CHG Solution and Bactec bottle components inside.
Product
MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0121-2023·2022-11-02
Medline Peripheral Blood Culture Draw Kit Recall: Incorrect Expiration Dates
Medline is recalling 1,020 peripheral blood culture draw kits due to incorrect expiration dates on kit components. The CHG solution and Bactec bottle plastic have expiration dates that do not match the date listed on the kit.
Product
MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0026-2023·2022-10-19
Medical device retrieval basket labels show incorrect expiration dates
Hobbs Medical recalls the Helical Retrieval Basket due to labels displaying incorrect expiration dates that extend the device's shelf life. Affected units distributed worldwide from March 2018 to September 2020 may be used beyond their validated lifespan.
Product
Hobbs Helical Retrieval Basket Catalog Number: 4806
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0060-2023·2022-10-19
Freeman Pancreatic Flexi-Stent Recall Due to Incorrect Expiration Date
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on product labels. The incorrect dates extend the shelf life, potentially allowing use beyond the actual safe expiration.
Product
Freeman Pancreatic Flexi-Stent Catalog Number: 6562
Category
Medical Device
Distribution
Distributed nationwide