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.

5151–5175 of 9610

  • ModerateFDA (Devices)·Z-0580-2017·2016-11-23

    Atrium Medical Recalls Trocar Catheters Due to Labeling Error

    Atrium Medical is recalling 20 Fr Trocar catheters because the packaging labels show more holes than the product actually contains.

    Product
    Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0403-2017·2016-11-23

    Bard Fluoro-4 Silicone Ureteral Stent Recall for Labeling Update

    C.R. Bard is recalling 75,089 units of Bard Fluoro-4 Silicone Ureteral Stents to add a warning about potential knots during removal.

    Product
    Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0406-2017·2016-11-23

    C.R. Bard Recalls Totalis Endo Kits for Labeling Update

    C.R. Bard is recalling 75,089 Totalis endo kits to add a warning about potential knots during removal.

    Product
    Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0405-2017·2016-11-23

    Bard Inlay Optima Ureteral Stent Recalled for Labeling Update

    C.R. Bard is recalling 75,089 Bard Inlay Optima ureteral stents to add a warning about potential knots during removal.

    Product
    Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0609-2017·2016-11-23

    Trilliant Surgical Recalls Cannulated Headless Screws Due to Labeling Errors

    Trilliant Surgical Ltd. is recalling 11 units of Model 208-70-110 cannulated headless screws because they bear incorrect part and lot numbers on the labels.

    Product
    Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0576-2017·2016-11-23

    Atrium Medical Recalls 8 Fr Trocar Catheters Due to Labeling Error

    Atrium Medical is recalling 8 Fr Trocar catheters because the packaging label displays an icon with more holes than the actual product contains.

    Product
    Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0581-2017·2016-11-23

    Atrium Medical 24 Fr Trocar Catheter Recall for Labeling Error

    Atrium Medical is recalling 24 Fr Trocar Catheters because the packaging label incorrectly depicts more holes than the product actually contains.

    Product
    Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0578-2017·2016-11-23

    Atrium Medical Recalls 12 Fr Trocar Catheters Due to Labeling Error

    Atrium Medical is recalling 12 Fr Trocar catheters because the packaging labels show more holes than the product actually contains.

    Product
    Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0588-2017·2016-11-23

    Alere Triage Total 5 Control Level 1 Recalled for Incorrect Ranges

    Alere San Diego, Inc. is recalling 513 kits of Alere Triage Total 5 Control Level 1 because the product was encoded with incorrect ranges that do not match the Expected Value Card.

    Product
    Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0577-2017·2016-11-23

    Atrium Medical Recalls Trocar Catheters Due to Inaccurate Labeling

    Atrium Medical is recalling 10 Fr Trocar catheters because the packaging label displays more holes than the product actually contains.

    Product
    Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0579-2017·2016-11-23

    Atrium Medical 16 Fr Trocar Catheter Labeling Error Recall

    Atrium Medical is recalling 16 Fr Trocar Catheters because the packaging labels show more eyelets than the product actually contains.

    Product
    Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0583-2017·2016-11-23

    Atrium Medical Recalls 32 Fr Trocar Catheters Due to Labeling Error

    Atrium Medical is recalling 32 Fr Trocar catheters because the packaging label depicts more eyelets than the product actually contains.

    Product
    Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0408-2017·2016-11-23

    Beckman Coulter Recalls Access Ostase QC for Expiration Date Issues

    Beckman Coulter is recalling Access Ostase QC kits because they do not meet expiration date claims within 10% criteria.

    Product
    Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0582-2017·2016-11-23

    Atrium Medical Recalls 28 Fr Trocar Catheters Due to Labeling Error

    Atrium Medical is recalling 28 Fr Trocar catheters because the packaging label incorrectly depicts more holes than the product actually contains.

    Product
    Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0402-2017·2016-11-23

    Siemens Recalls Dimension IRON Flex Reagent Cartridges Due to Interference

    Siemens Healthcare Diagnostics is recalling Dimension IRON Flex reagent cartridges because deferoxamine interferes with the assay at a different concentration than listed in the instructions.

    Product
    Dimension IRON Flex reagent cartridges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0594-2017·2016-11-23

    Philips Brilliance CT System Recalled for Incorrect Label Rating

    Philips is recalling three Brilliance ICT SP CT systems because the product labels do not include the correct current rating.

    Product
    Brilliance ICT SP Computed Tomography X-ray system, Model 728311
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-0597-2017·2016-11-23

    Philips CT System Recalled for Incorrect Label Rating

    Philips is recalling two Ingenuity Core CT systems because the product labels do not include the correct current rating.

    Product
    Ingenuity Core Computed Tomography X-ray system, Model 728321
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-0598-2017·2016-11-23

    Philips IQon Spectral CT System Recalled for Incorrect Label Rating

    Philips Medical Systems is recalling three IQon Spectral CT systems because the product labels do not include the correct current rating.

    Product
    IQon Spectral CT Computed Tomography X-ray system, Model 728332
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-0401-2017·2016-11-23

    Siemens Recalls Dimension Vista IRON Flex Reagent Cartridges

    Siemens Healthcare Diagnostics is recalling Dimension Vista IRON Flex reagent cartridges due to deferoxamine interference at concentrations not listed in the Instructions for Use.

    Product
    Dimension Vista IRON Flex reagent cartridges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0139-2017·2016-11-23

    CutisPharma Recalls Omeprazole Compounding Kits Due to Labeling Error

    CutisPharma is recalling 5,904 kits of FIRST Omeprazole 2mg/mL because the package insert incorrectly lists the strength as 3mg/mL.

    Product
    FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0593-2017·2016-11-23

    Philips Brilliance iCT Computed Tomography System Recalled for Labeling Error

    Philips Medical Systems is recalling 67 Brilliance iCT Computed Tomography X-ray systems because the product labels do not include the correct current rating.

    Product
    Brilliance iCT Computed Tomography X-ray system, Model 728306
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Drugs)·D-0142-2017·2016-11-23

    GSK Recalls Zeasorb AF Antifungal Cream Due to Labeling Errors

    GSK Consumer Healthcare is recalling Zeasorb AF antifungal cream because some bottles have incorrect NDC codes or indications on the labels.

    Product
    Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0610-2017·2016-11-23

    OMNIBotics Tracker Kit Recalled for Incorrect Lot Number Labeling

    OMNI Life Science is recalling 15 OMNIBotics Tracker Kits due to incorrect lot numbers on the outer packaging.

    Product
    OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Drugs)·D-0138-2017·2016-11-23

    CutisPharma Recalls Omeprazole Kits Due to Labeling Error

    CutisPharma is recalling 8,748 Omeprazole compounding kits because the package insert incorrectly lists the strength as 3mg/mL instead of 2mg/mL.

    Product
    FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
    Category
    Drug
    Distribution
    Distributed nationwide