International Medsurg Connection, Inc.

International Medsurg Connection, Inc.: 59 FDA recall reports

Every medical device recall the FDA has published for International Medsurg Connection, Inc.. The fault, and how the agency graded it.

59Reports
0Class I
0Ongoing
2017-08-16Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II59
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The products are used to inject fluids in

Z-2856-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
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 disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from t

Z-2804-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Syringe Bulb, 60 CC 50 pcs per 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, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The produ

Z-2842-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
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, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 100 per box, 30 boxes/case, 3,000/case The produc

Z-2826-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 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 disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 boxes/case, 2,400/case The prod

Z-2833-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 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, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids int

Z-2853-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe, 5 CC L/L, 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 disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The products are used to inject fluids in

Z-2855-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product 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 disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/case The products are used to

Z-2813-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Hypodermic Needle, 21 G X 1.5 in YALE DISP, 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 prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The produ

Z-2836-201  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 25 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, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Hypodermic Needle, 20 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case The products are u

Z-2811-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Hypodermic Needle, 20 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, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used

Z-2805-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Hypodermic Needle, 16G X 1.5in 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 or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 5/8, 100 per box, 24 boxes/case, 2,400/case The produ

Z-2837-201  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 5/8, 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, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The prod

Z-2849-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.5, 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, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Hypodermic Needle, 22 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to

Z-2815-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support 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 prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Hypodermic Needle, 27 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The products are used to

Z-2821-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Hypodermic Needle, 27 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 prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids int

Z-2851-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
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 disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The prod

Z-2848-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product 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, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The produ

Z-2832-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 22 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, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The prod

Z-2845-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 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, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The prod

Z-2846-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product 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, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The prod

Z-2847-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 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, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into,

Z-2857-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/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, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 3 CC L/L 23 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The produ

Z-2835-201  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 23 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, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe, 3 CC L/S, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids int

Z-2852-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product 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 disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/case The products are used to inject fluids into,

Z-2862-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe, 60 CC L/S, 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, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Hypodermic Needle, 18 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to

Z-2807-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Hypodermic Needle, 18 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 prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The products are used to inject fluids int

Z-2850-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product 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 disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Hypodermic Needle, 25 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to

Z-2818-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Hypodermic Needle, 25 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 prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The produ

Z-2830-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 21 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, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case

Z-2827-2017  ·  Class II  ·  reported 2017-08-16  ·  Terminated

Why it was recalled
Insufficient 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
Where it went
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
How much
54,204,100 units total

Showing the 30 most recent of 59. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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