Hazard

Specification Non Compliance 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: 2024-09-18

Of the 15 specification non compliance 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 specification non compliance 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

HighFDA (Devices)·Z-3078-2024·2024-09-18
Multiple Syringe Models Recalled for Deviation from FDA Clearance Specifications
Sol-Millennium Medical is recalling multiple syringe models because the distributed products are substantially different from FDA-cleared specifications, with major changes to the intended use.
Product
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Ex
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2059-2024·2024-05-29
MEDLINE Non-Sterile Syringes Recalled: Sizes Outside FDA Clearance Range
MEDLINE non-sterile syringes (Model 91827) are recalled because piston sizes and configurations are outside the FDA clearance range. The manufacturer is recalling 44,800 units distributed in six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2024·2024-05-29
Wolf Medical Syringes Recalled for Exceeding Approved Specifications
Wolf Medical 20 mL syringes are recalled because their piston syringe sizes and configurations exceed FDA-approved specifications under the manufacturer's 510(k) clearance. Approximately 378,900 units were distributed nationwide in six states.
Product
Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0385-2024·2024-03-20
Antibiotic Injection Recalled for Failed Stability Specification
Eugia US LLC is recalling 1,160 vials of Tobramycin for Injection due to failed water determination testing. Affected lot numbers are 3TB23001 and 3TB23002, expiring 04/30/2025.
Product
TOBRAMYCIN — TOBRAMYCIN (TOBRAMYCIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2024·2023-12-13
Intraocular Lens Implants Recalled for Specification Non-Compliance
Staar Surgical recalls six EVO+VISIAN intraocular lens implants due to potential specification non-compliance. The affected units were distributed across 38 US states.
Product
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0468-2024·2023-12-13
EVO VISIAN intraocular lens recalled for potential specification non-compliance
Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.
Product
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0474-2024·2023-12-13
EVO VISIAN Intraocular Lenses recalled for potential specification defects
Staar Surgical Company is recalling 9 EVO VISIAN intraocular lenses due to potential specification non-compliance. The affected devices were distributed to 40 US states.
Product
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0466-2024·2023-12-13
EVO+VISIAN Implantable Collamer Lens Recalled for Specification Non-Compliance
Staar Surgical recalls 51 EVO+VISIAN intraocular lenses due to potential specification non-compliance. Affected devices were distributed across multiple U.S. states.
Product
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0472-2024·2023-12-13
Intraocular Lens Implants Recalled Due to Potential Specification Non-Compliance
Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.
Product
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Category
Medical Device
Distribution
38 states
ModerateFDA (Devices)·Z-0470-2024·2023-12-13
Intraocular Lens Devices May Not Meet Manufacturing Specifications
Staar Surgical is recalling 3 units of its EVO+VISIAN Implantable Collamer Lens (phakic toric) due to a potential that devices may not meet specifications. No illnesses or injuries have been reported.
Product
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-2046-2023·2023-07-05
Knee Prosthesis System Components Recalled for Specification Non-Compliance
Waldemar Link GmbH & Co. KG is recalling 21 units of LINK Endo-Model Modular Knee Prosthesis System Femoral Segment components because they may not meet manufacturing specifications. No injuries have been reported.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0110-2023·2022-10-26
Oral Tip Syringes Recalled Due to Unapproved Plunger Material
Medicina Oral Tip Syringes are being recalled because the plunger component was made with polyethylene instead of the approved polypropylene material. No illnesses or injuries have been reported.
Product
Medicina Oral Tip Syringe 1ml Code: OT01
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0954-2022·2022-04-27
Medical Device Reference Standard Recalled for Inadequate Quality Control Process
Microbiologics Inc recalls an inactivated Mycoplasma genitalium reference standard (Lot HE0069-02-1) because its quality control process did not meet specification requirements. This reference material is used in diagnostic and laboratory testing.
Product
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2022·2022-04-20
CLARAVUE Pre-wired Electrode fails to meet electrical safety specification
Graphic Controls' CLARAVUE Pre-wired Electrode units fail to meet electrical safety specifications required for defibrillation. The device delivers an inefficient electrical charge and may result in ineffective defibrillation.
Product
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0891-2022·2022-04-13
Abbott ARCHITECT STAT myoglobin calibrators recalled for calibration failure
Abbott is recalling 402 kits of ARCHITECT STAT myoglobin calibrator that failed stability testing and may produce out-of-specification calibration results. The affected calibrators could impact the accuracy of myoglobin measurements used in clinical diagnostics.
Product
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide