thejoe The Metrix Company

The Metrix Company: 33 FDA recall reports

Every medical device recall the FDA has published for The Metrix Company. The fault, and how the agency graded it.

33Reports

0Class I

24Ongoing

2024-11-20Most 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.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It 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

Class	Reports
Class II	33

By year reported

Year	Reports
2016	8
2017	1
2019	8
2024	16

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.

SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended

Z-0339-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 2921 cases of 50 units

SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended

Z-0335-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 2229 cases of 50 units

Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended t

Z-0344-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 864 cases of 50 units

VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intende

Z-0330-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 288 cases of 50 units

Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended t

Z-0342-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 768 units

CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intende

Z-0332-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 1920 cases of 50 units

SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended t

Z-0337-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 1013 cases of 50 units

Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended t

Z-0343-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 1056 cases of 50 units

CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intende

Z-0334-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 1440 cases of 50 units

CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intende

Z-0333-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 3456 cases of 50 units

SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of pla

Z-0336-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 2549 cases of 50 units

SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of pla

Z-0338-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 83 cases of 50 units

VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intende

Z-0331-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 384 cases of 50 units

SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended

Z-0340-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 1020 cases of 50 units

Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended

Z-0345-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 96 cases of 50 units

SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended

Z-0341-2025 · Class II · reported 2024-11-20 · Ongoing

Why it was recalled: A limited number of IV bags have been found to leak during filling.
Product: SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Where it went: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
How much: 277 cases of 50 units

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For us

Z-0003-2020 · Class II · reported 2019-10-09 · Ongoing

Why it was recalled: Potential for leaking product
Product: SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Where it went: US Nationwide distribution including the states of PA, MA, IL CA.
How much: 1512 bags

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage:

Z-0004-2020 · Class II · reported 2019-10-09 · Ongoing

Why it was recalled: Potential for leaking product
Product: SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Where it went: US Nationwide distribution including the states of PA, MA, IL CA.
How much: 141120 bags

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage:

Z-0005-2020 · Class II · reported 2019-10-09 · Ongoing

Why it was recalled: Potential for leaking product
Product: SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Where it went: US Nationwide distribution including the states of PA, MA, IL CA.
How much: 234720 bags

ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter -

Z-0008-2020 · Class II · reported 2019-10-09 · Ongoing

Why it was recalled: Potential for leaking product
Product: ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Where it went: US Nationwide distribution including the states of PA, MA, IL CA.
How much: 332640 bags

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For us

Z-0001-2020 · Class II · reported 2019-10-09 · Ongoing

Why it was recalled: Potential for leaking product
Product: SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Where it went: US Nationwide distribution including the states of PA, MA, IL CA.
How much: 1596 bags

ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter -

Z-0007-2020 · Class II · reported 2019-10-09 · Ongoing

Why it was recalled: Potential for leaking product
Product: ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Where it went: US Nationwide distribution including the states of PA, MA, IL CA.
How much: 175392 bags

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage:

Z-0006-2020 · Class II · reported 2019-10-09 · Ongoing

Why it was recalled: Potential for leaking product
Product: SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Where it went: US Nationwide distribution including the states of PA, MA, IL CA.
How much: 54720 bags

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For us

Z-0002-2020 · Class II · reported 2019-10-09 · Ongoing

Why it was recalled: Potential for leaking product
Product: SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Where it went: US Nationwide distribution including the states of PA, MA, IL CA.
How much: 4284 bags

SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,

Z-3240-2017 · Class II · reported 2017-10-11 · Terminated

Why it was recalled: The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.
Product: SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Where it went: AZ, MA, IL, FL
How much: 50 cases of 200 units

AUTOCOMP6 XPS High Speed Compounder REF 58810

Z-2257-2016 · Class II · reported 2016-08-03 · Terminated

Why it was recalled: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Product: AUTOCOMP6 XPS High Speed Compounder REF 58810
Where it went: Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
How much: 16 devices

AUTOCOMP6 High Speed Compounder

Z-2259-2016 · Class II · reported 2016-08-03 · Terminated

Why it was recalled: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Product: AUTOCOMP6 High Speed Compounder
Where it went: Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
How much: 323

AUTOCOMP6 XP High Speed Compounder REF 58810

Z-2258-2016 · Class II · reported 2016-08-03 · Terminated

Why it was recalled: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Product: AUTOCOMP6 XP High Speed Compounder REF 58810
Where it went: Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
How much: 93 devices

Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 m

Z-2261-2016 · Class II · reported 2016-08-03 · Terminated

Why it was recalled: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Product: Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
Where it went: Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
How much: 18,366 cases

Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.

Z-2260-2016 · Class II · reported 2016-08-03 · Terminated

Why it was recalled: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Product: Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
Where it went: Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
How much: 137,598 cases

Showing the 30 most recent of 33. 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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