The Recall Desk

Hazard

Specification Deviation recalls

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

What the numbers show

Total
18
Critical
0
Severe
1
Most recent
2026-07-01

Of the 18 specification deviation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) 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 deviation 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.

1–18 of 18

  • SevereFDA (Devices)·Z-2593-2026·2026-07-01

    Medline convenience kits recalled for unapproved syringe design changes

    Medline Industries recalls convenience kits containing 10mL polycarbonate colored syringes because design changes were made outside of FDA-cleared specifications. The recall affects approximately 113,843 kits distributed nationwide.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2026·2026-05-13

    BioCera Fibers Bioresorbable Bone Void Filler Recall

    Orthorebirth Co Ltd is recalling BioCera Fibers, a bioresorbable bone void filler, because the product falls outside standard specifications. The recall affects 1266 units distributed nationwide in California and Florida.

    Product
    BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2026·2025-12-24

    Pectoral implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 41 AART Pectoral Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 si
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0947-2026·2025-12-24

    Malar facial implants recalled over specification deviations and missing clearance

    DSAART is recalling 2 AART Malar Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0949-2026·2025-12-24

    Calf implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 35 AART Calf Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0944-2026·2025-12-24

    Silicone carving implants recalled over specification deviations and missing clearance

    DSAART is recalling 369 AART Silicone Carving Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carvi
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0945-2026·2025-12-24

    Gluteal implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 118 AART Gluteal Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0946-2026·2025-12-24

    Chin implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 29 AART Chin Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 40
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2067-2024·2024-05-29

    Medline 20mL Non-Sterile Syringes Recalled for Design Specification Deviation

    Medline non-sterile 20mL syringes (Model 91835) are being recalled because the piston sizes and configurations do not match FDA-cleared specifications. Approximately 39,200 units are affected.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2024·2024-05-29

    Non-sterile Piston Syringes Distributed Outside FDA-Approved Specifications

    Medline piston syringes (Model 83083) manufactured by Jiangsu Shenli are being recalled because their sizes and configurations fall outside FDA-approved specifications. Approximately 494,000 units are affected across the United States.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2023·2023-07-19

    Medical Blood Cell Diluent Recalled for Out-of-Specification Parameters

    Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.

    Product
    COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0824-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Drums Recalled for Low Levels

    Fresenius Medical Care is recalling 27 drums of NaturaLyte Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0725-2018·2018-03-07

    Terumo Destination Guiding Sheath Recalled for Specification Deviation

    Terumo Medical Corporation is recalling 33 units of Destination Guiding Sheath catheter introducers because the tucking depth feature is marginally outside the upper specification.

    Product
    Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, caroti
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1432-2014·2014-07-23

    Poly Pharmaceuticals Recalls Lortuss Ex Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 102 bottles of Lortuss Ex because the product does not meet monograph specifications and has inaccurate labeling.

    Product
    LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1860-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks used in home dialysis systems because aluminum levels exceeded internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialy
    Category
    Medical Device
    Distribution
    Distributed nationwide