Hazard

Sterility Claim recalls

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

What the numbers show

Total: 23
Critical: 0
Severe: 0
Most recent: 2017-08-16

Of the 23 sterility claim 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 sterility claim 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.

1–23 of 23

ModerateFDA (Devices)·Z-2843-2017·2017-08-16
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because of insufficient documentation to support sterility claims.
Product
Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2848-2017·2017-08-16
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because the company lacks sufficient documentation to support the products' sterility claims.
Product
Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigatio
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2842-2017·2017-08-16
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because of insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2829-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54.2 million piston syringes and hypodermic needles because documentation supporting sterility claims is insufficient.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2827-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles because the company lacks sufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2806-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54.2 million hypodermic needles because documentation supporting their sterility claims is insufficient.
Product
Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment o
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2809-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.
Product
Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatme
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2855-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 10 cc piston syringes because the company lacks sufficient documentation to support the products' sterility claims.
Product
Piston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of dis
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2820-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.
Product
Hypodermic Needle, 27 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2861-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 60 CC piston syringes because the company lacks documentation to support the products' sterility claims.
Product
Piston Syringe, 60 CC L/L, 50 per box, 8 boxes/case, 400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2823-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.
Product
Hypodermic Needle, 30 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2854-2017·2017-08-16
International Medsurg Piston Syringes Recalled for Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.
Product
Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of diseas
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2828-2017·2017-08-16
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because of insufficient documentation to support sterility claims.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2850-2017·2017-08-16
International Medsurg Piston Syringes Recalled for Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.
Product
Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of dise
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2824-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.
Product
Hypodermic Needle, 30 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2846-2017·2017-08-16
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles nationwide because of insufficient documentation to support sterility claims.
Product
Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigatio
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2856-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because documentation supporting their sterility claims is insufficient.
Product
Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of dis
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2852-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.
Product
Piston Syringe, 3 CC L/S, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of dise
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2814-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling hypodermic needles because documentation supporting sterility claims is insufficient. The recall covers 54,204,100 units distributed nationwide.
Product
Hypodermic Needle, 22 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2851-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54.2 million piston syringes because documentation supporting their sterility claims is insufficient.
Product
Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of dise
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2815-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support its product sterility claims.
Product
Hypodermic Needle, 22 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-228-2013·2013-04-03
CareFusion Recalls Donor Prep Kits Due to Misleading Sterility Labeling
CareFusion 213, LLC is recalling 46,500 Donor Prep Kits because the labeling is misleading regarding sterility claims. The product is not sterile.
Product
Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-225-2013·2013-04-03
CareFusion Recalls SEPP 2% Iodine Tincture Applicators for Sterility Mislabeling
CareFusion 213, LLC is recalling SEPP 2% Iodine Tincture applicators because the product is not sterile, making the labeling misleading regarding sterility claims.
Product
SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.
Category
Drug
Distribution
Distributed nationwide