Hazard

Labeling Mismatch recalls

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

What the numbers show

Total: 15
Critical: 0
Severe: 0
Most recent: 2025-07-02

Of the 15 labeling mismatch recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 labeling mismatch 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.

1–15 of 15

ModerateFDA (Devices)·Z-2011-2025·2025-07-02
Altivate Reverse Torx Peripheral Screw package labeling mismatch
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because the package labeling lists a different size than the actual product included inside.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-2009-2025·2025-07-02
Altivate Reverse Torx Peripheral Screw labeling mismatch recall
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling lists a different size than the actual product included inside.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-1813-2025·2025-05-28
HiResolution Bionic Ear System M Battery Charger Labeling Mismatch Recall
Advanced Bionics, LLC is recalling six units of the HiResolution Bionic Ear System - M Battery Charger (Model CI-5607) due to incorrect product labeling that does not match the intended product.
Product
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0964-2024·2024-02-07
Blood Culture Bottle Kit Recalled for Expired Component Documentation Issue
Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.
Product
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0663-2024·2024-01-17
Baxter Flo-Thru Intraluminal Shunt recalled for marketing brochure inaccuracy
Baxter Healthcare is recalling marketing materials for the Flo-Thru Intraluminal Shunt due to inaccurate content that does not match the product's official instructions for use or prescribing information.
Product
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2024·2023-12-20
Sterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling
Medline Industries is recalling sterile prep sticks (REF DYNDA1134) labeled as sterile that contain non-sterile solution, posing infection risk in medical procedures.
Product
STERILE STERILE PREP STICK, REF DYNDA1134
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0509-2024·2023-12-20
Spectranetics Turbo-Elite Atherectomy Catheters recalled due to labeling mismatch
Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters due to incorrect labeling where the exterior product box label does not match the internal pouch label.
Product
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1041-2023·2023-02-08
Biopsy marker device recalled for label and contents mismatch
Carbon Medical Technologies recalls 550 Mammotome MammoStar biopsy markers due to a labeling error. The label identifies one product but the package contains a different marker size and shape.
Product
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0162-2023·2023-01-25
Levofloxacin Tablets Recalled for Embossing and Packaging Insert Mismatch
Macleods Pharma USA recalls Levofloxacin Tablets 500 mg due to mismatched embossing on tablets versus the package insert labeling. The distributed bottles do not match the documented tablet markings.
Product
Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0006-2023·2022-10-12
Orthopedic implant recall due to labeling mismatch on Stryker EVOLVE Proline Stem
Wright Medical Technology recalls 32 units of Stryker EVOLVE Proline Stem due to labeling mismatch: outer packages are labeled with one stem size but contain a different size. Surgeons should verify device size before implantation.
Product
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0334-2022·2021-12-15
Orthodontic Software Documentation Recalled for Unapproved Labeling Changes
Orchestrate Orthodontic Technologies recalls O3D ORCHESTRATE user documentation because the labeling was altered from its FDA-approved version. Approximately 127 copies were distributed to practitioners worldwide.
Product
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0085-2022·2021-10-20
Spinal Implant Engraving May Not Match Pouch Labels
Medtronic Sofamor Danek is recalling the Endoskeleton TAS Interbody System because the engraving on the implants may not match the information on the pouch labels.
Product
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0086-2022·2021-10-20
Endoskeleton TCS Interbody System implant engraving may not match pouch labels
Medtronic is recalling 9 Endoskeleton TCS Interbody System surgical implants because engraving on the devices may not match the labels on the pouches. The mismatch could result in wrong devices being implanted.
Product
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2250-2021·2021-08-18
Exactech BIOLOX Delta Femoral Head Hip Prosthesis Recalled for Device Marking Mismatch
Exactech is recalling 29 BIOLOX delta femoral head hip prosthesis components due to a discrepancy between the product label and actual device marking. The mismatch could affect proper device identification and surgical placement.
Product
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2209-2021·2021-08-18
Prime TC Transport Chair Recalled for Improper Residential Distribution
The Prime TC-transport chair, designed for healthcare facility use, was distributed to residential customers who may not understand the professional-level operating instructions. The recall addresses potential risk of improper use by home users.
Product
Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000¿¿¿¿¿¿¿
Category
Medical Device
Distribution
Distributed nationwide