The Recall Desk

Hazard

Mis Labeling recalls

9,610 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,610
Critical
161
Severe
588
Most recent
2026-09-16

Of the 9,610 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 588 (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.

5476–5500 of 9610

  • ModerateFDA (Devices)·Z-2195-2016·2016-07-20

    Synthes Recalls 34 Stardrive Screwdrivers for MR Safety Labeling Errors

    Synthes (USA) Products LLC is recalling 34 units of 1.3mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.

    Product
    Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2155-2016·2016-07-20

    Synthes 4.0 mm Cortex Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 4.0 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1354-2016·2016-07-20

    Wupooser Kai Yeung Pill Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Wupooser Kai Yeung Pill because it is marketed with drug claims without FDA approval.

    Product
    WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2198-2016·2016-07-20

    Synthes Recalls 2.0mm Stardrive Screwdriver for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 36 units of 2.0mm Stardrive Screwdrivers because their MR safety labeling does not meet current ASTM standards.

    Product
    Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2203-2016·2016-07-20

    Roche Recalls Influenza Quality Control Kits Due to Incorrect Expiration Dates

    Roche Molecular Systems is recalling 194 cobas Liat Influenza A/B Quality Control Kits because they are labeled with incorrect expiration dates.

    Product
    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
    Category
    Medical Device
    Distribution
    16 states
  • LowFDA (Devices)·Z-2148-2016·2016-07-20

    Breathe Right Clear Nasal Strips Recalled for Incorrect Packaging Labels

    GSK Consumer Healthcare is recalling Breathe Right Clear nasal strips because some secondary packaging cartons were incorrectly labeled for the AU/NZ market.

    Product
    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2143-2016·2016-07-20

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling 30 enGen Laboratory Automation Systems due to a software error that displays incorrect interpretive text for certain test results.

    Product
    enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1624-2016·2016-07-13

    Wegmans Brownie with Icing Recalled for Undeclared Milk Allergen

    Wegmans Food Markets is recalling 16 oz. Brownie with Icing pans due to an undeclared milk allergen. The product was distributed in six states.

    Product
    Wegmans Brownie with Icing, Pan, 16 oz., UPC#7789082502
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1066-2016·2016-07-13

    QuVa Pharma Recalls Phenylephrine Syringes Due to Labeling Error

    QuVa Pharma is recalling 20 cases of Phenylephrine syringes because some units have incorrect strength labels on the protective overwrap.

    Product
    PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1068-2016·2016-07-13

    Reliable Compounding Pharmacy Recalls Biotin Capsules Due to Labeling Error

    Reliable Compounding Pharmacy is recalling Biotin 100 mg capsules because they were found to contain 4-aminopyridine instead of the labeled ingredient.

    Product
    CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Food)·F-1629-2016·2016-07-13

    Way Fong Recalls Fried Shrimp Flavoured Fish Bar for Undeclared Egg Allergen

    Way Fong LLC is recalling 15 cases of Fried Shrimp Flavoured Fish Bar in New York due to the presence of undeclared egg allergen.

    Product
    FRIED SHRIMP FLAVOURED FISH BAR, Net Wt 9.07 Kg 4 X 5 lbs. bulk, Product of Canada, KEEP REFRIGERATED
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2083-2016·2016-07-13

    Medtronic Navigation O-arm 02 surgical x-ray system recalled for labeling gaps

    Medtronic Navigation is recalling 63 O-arm 02 surgical x-ray imaging systems nationwide due to gaps in electronic product labeling and Instructions for Use compliance.

    Product
    Medtronic Navigation O-arm 02 surgical x-ray imaging system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2126-2016·2016-07-13

    Anspach Effort Recalls Battery Oscillators with Incorrect Mode Switch Labels

    The Anspach Effort, Inc. is recalling 20 Battery Power Line II Battery Oscillators because the mode switch ring has incorrect operating directions.

    Product
    Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2133-2016·2016-07-13

    Cadillac First Aid Kit Recalled for Prescription-Only CPR Mask

    Lifeline First Aid LLC is recalling Cadillac First Aid Kits because they contain a CPR mask cleared only for prescription use, not over-the-counter.

    Product
    5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2138-2016·2016-07-13

    Synthes Ti Button Plate Recalled for Inaccurate MR Safety Labeling

    Synthes (USA) Products LLC is recalling 6,255 Ti Button Plate units because their MR safety information does not meet current ASTM standards.

    Product
    Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-2121-2016·2016-07-13

    ZYTO Software Recalled for Exceeding 510(k) Clearance Claims

    ZYTO Technologies is voluntarily recalling ZYTO Tower and software programs because their claims exceeded the scope of their FDA 510(k) clearance.

    Product
    The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2136-2016·2016-07-13

    Arrow Recalls Central Venous Catheters Due to Length Mismatch

    Arrow International Inc. is recalling specific lots of central venous catheters because kits labeled for 20 cm catheters may contain 16 cm catheters.

    Product
    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2128-2016·2016-07-13

    Exactech Recalls Novation Hip Stems Due to Incorrect GTIN Labeling

    Exactech is recalling 14 Novation femoral stems because they were labeled with an incorrect Global Trade Item Number (GTIN). The error identifies the devices as a different product.

    Product
    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2127-2016·2016-07-13

    Exactech Recalls Hip Replacement Stems Due to Incorrect GTIN Labeling

    Exactech is recalling 8 units of Novation Press-Fit Splined Femoral Stems because they are labeled with an incorrect Global Trade Item Number (GTIN).

    Product
    Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V514000·2016-07-07

    Jayco Recalls 2017 Jay Flight SLX Travel Trailers for Incorrect Weight Labels

    Jayco is recalling 32 model year 2017 Jay Flight SLX travel trailers because incorrect weight labels may allow operators to overload the vehicle, increasing crash risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT SLX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·16V516000·2016-07-07

    GM Recalls 2016-2017 Buick Envision for Incorrect Tire Label Weight

    General Motors is recalling 2016-2017 Buick Envision vehicles because the Tire and Loading Information label may display incorrect maximum weight information, which could lead to vehicle overloading.

    Product
    BUICK — BUICK ENVISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1591-2016·2016-07-06

    Eban's BAKEHOUSE Crispy Pecan Shortbread Cookies Recalled for Coconut Allergen Mislabeling

    Eban Bakery is recalling Crispy Pecan Shortbread Cookies because the label failed to list coconut in the 'Contains' section, despite it being in the ingredients.

    Product
    Product is labeled as "eban's BAKEHOUSE CRISPY PECAN SHORTBREAD COOKIES Net Weight 8.5 oz (241g) " . The cookies are packaged 6 per container. The container is a plastic tub with lid and tamper proof band.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2099-2016·2016-07-06

    Dako HER2 CISH pharmDx Kit Recalled for Incorrect Probe Concentration

    Dako North America Inc. is recalling 31 kits of the HER2 CISH pharmDx Kit because the HER2 probe concentration was too low.

    Product
    Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromer
    Category
    Medical Device
    Distribution
    Distributed nationwide