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.

5401–5425 of 9610

  • ModerateFDA (Devices)·Z-2404-2016·2016-08-17

    Medline Medicine Cups Recalled for Incorrect Volume Markings

    Medline Industries is recalling 1-ounce medicine cups because the 10 mL increment is incorrectly printed as 5 mL, creating a risk of medication dosing errors.

    Product
    Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2375-2016·2016-08-17

    Nobel Biocare Recalls Guided Surgery Kit Instructions for Incorrect Drill Protocol

    Nobel Biocare is recalling 231 Guided Surgery Kits because the Instructions for Use contain an incorrect drill protocol. The kits are used for NobelParallel CC Implants.

    Product
    Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2365-2016·2016-08-17

    Invacare Pediatric Flowmeter Recalled Due to Upside-Down Rear Scale

    Invacare is recalling 395 Precise Rx Pediatric Flowmeters because the rear gradation scale was printed upside down, which may confuse users.

    Product
    Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the pri
    Category
    Medical Device
    Distribution
    30 states
  • LowFDA (Devices)·Z-2378-2016·2016-08-17

    BD Tritest CD3/CD4/CD45 Reagent Recalled for Incorrect Labeling

    Becton, Dickinson and Company is recalling 14,089 vials of BD Tritest CD3 FITC/CD4 PE/CD45 PerCP because the label incorrectly states the product contains gelatin.

    Product
    BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protei
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2345-2016·2016-08-17

    Medivance ArcticGel Neonatal Pad Recalled for Missing Multilingual Instructions

    C.R. Bard is recalling 64 Medivance ArcticGel Neonatal Pads because the included instructions were missing required languages for CE-marked products.

    Product
    Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2326-2016·2016-08-10

    Mentor MemoryGel Breast Implant Recall Due to Missing Date Labels

    Mentor Texas, LP is recalling 35 units of 300cc MemoryGel Breast Implants because the boxes were labeled with null manufacturing and expiration dates.

    Product
    Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2330-2016·2016-08-10

    Dako EnVision FLEX+ Mouse High pH Kits Recalled for pH Error

    Dako Denmark A/S is recalling 147 kits of EnVision FLEX+ Mouse, High pH (Link) because the Target Retrieval Solution has an incorrect pH level.

    Product
    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2304-2016·2016-08-10

    Roche Recalls Vancomycin Assay Kits Due to Incorrect Method Sheets

    Roche Diagnostics is voluntarily recalling Vancomycin assay kits because method sheets contain incorrect comparison data for specific analyzers.

    Product
    ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2333-2016·2016-08-10

    C.R. Bard Recalls SureStep Urine Collection System for Labeling Issues

    C.R. Bard is recalling 530 SureStep urine collection systems due to a labeling problem. The recall is voluntary and nationwide.

    Product
    SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2327-2016·2016-08-10

    Teleflex Horizon 24 Titanium Clips Recalled for Missing Date Labels

    Teleflex Medical is recalling Horizon 24 Large Titanium Clips because manufacturing and expiration dates are missing from the blister pack labels.

    Product
    Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is
    Category
    Medical Device
    Distribution
    20 states
  • CriticalFDA (Food)·F-1843-2016·2016-08-03

    DF Mavens Chocolate Almond Fudge Frozen Bars Recalled for Undeclared Milk

    FAL FOODS USA Inc. is recalling DF Mavens Chocolate Almond Fudge Frozen Bars because FDA testing confirmed the presence of undeclared milk allergen.

    Product
    DF Mavens Chocolate Almond Fudge Frozen Bars, Net 11.52 fl. oz. (340 mL), 4 bars per box, each bar is 2.88 Fl. Oz., UPC 857756004772 --- DF Mavens, a subsidiary of FAL FOODS USA Inc., 24-20 49th Street - Astoria, NY 11103 --- Product is labeled as "Dairy Free".
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1841-2016·2016-08-03

    7-Eleven Oatmeal Raisin Cookies Recalled for Undeclared Peanuts

    Bakery Express of Southern California is recalling 7-Eleven Fresh To Go Oatmeal Raisin Cookies due to undeclared peanuts. The product was distributed to retail stores in Southern California.

    Product
    7-ELEVEN FRESH TO GO OATMEAL RAISIN COOKIE NET WT. 4.0 OZ UPC: 052548558758
    Category
    Food
    Distribution
    1 state
  • HighUSDA FSIS·069-2016·2016-08-03

    Grossglockner Recalls Pork Sausage Due to Undeclared Wheat Allergen

    Grossglockner Inc. is recalling approximately 204 pounds of pork sausage bangers because the packaging labels failed to declare wheat, a common allergen.

    Product
    Grossglockner Inc. — Grossglockner Inc. Recalls Pork Products Due To Misbranding
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1834-2016·2016-08-03

    Casey's Bakery Almond Patties Recalled for Undeclared Milk Allergen

    Casey's Bakery is recalling Almond Patties because the product contains butter but fails to declare the milk allergen.

    Product
    Casey's Bakery, Almond Patties, Traditional Dutch Puff Pastry Filled with Pure Almond Paste, 6 Patties, NET WT 13.5 OZ
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2300-2016·2016-08-03

    Ge Healthcare Recalls Imagecast PACS Software Due to Image Context Defect

    Ge Healthcare is recalling Imagecast PACS software versions prior to 10.6 Update Package 18 because a defect causes images to be out of context with clinical information.

    Product
    Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general pur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2289-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 20 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, while it is only intended for cardiovascular use.

    Product
    AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2297-2016·2016-08-03

    Smith & Nephew Recalls Spherical Head Reflection Cancellous Screws Due to Labeling Error

    Smith & Nephew is recalling 185 units of Spherical Head Reflection 6.5 mm Cancellous Screws because the packaging contained 35mm screws instead of the labeled 25mm size.

    Product
    SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a resul
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2284-2016·2016-08-03

    LeMaitre Vascular Recalls AnastoClip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 471 units of AnastoClip AC Clips because marketing materials incorrectly suggested they could be used for dura closure.

    Product
    AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2285-2016·2016-08-03

    LeMaitre Vascular Recalls Anasto AC Closure System for Mislabeling

    LeMaitre Vascular is recalling 170 units of the Anasto AC Closure System because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intend
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2286-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, though it is only intended for cardiovascular use.

    Product
    AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1848-2016·2016-08-03

    SCD Probiotics Recalls Xtra Immunity Brown Rice Antioxidant Probiotic Extract

    Sustainable Community Development LLC is recalling Xtra Immunity Brown Rice Antioxidant Probiotic Extract because the dietary supplement contains drug claims, making it misbranded.

    Product
    Xtra Immunity Brown Rice Antioxidant Probiotic Extract, a liquid packaged in a 500mL bottle. UPC 184368000114. The responsible firm name on the label is SCD Probiotics, Kansas City, MO 64106.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2298-2016·2016-08-03

    Siemens Syva EMIT 2000 Theophylline Reagent Recall for Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Syva EMIT 2000 Theophylline reagents due to potential increased imprecision when used with certain quality control materials.

    Product
    Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2288-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 55 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2283-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip AC Clips Due to Mislabeling

    LeMaitre Vascular is recalling 256 units of Anastoclip AC Clips because marketing materials incorrectly stated they could be used for dura closure.

    Product
    Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an acces
    Category
    Medical Device
    Distribution
    Distributed nationwide