Cardinal Health Monoject Needles Recall: Sterility Risk from Manufacturing Defect
Cardinal Health recalls 20G x 1.5" Monoject needles due to potential sterility compromise from manufacturing defects. Affected lots: 905657, 906327, 906341.
Lower-risk recall
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Contact the company
What happened, in plain English
Cardinal Health is recalling a specific type of medical needle because a manufacturing defect might compromise its sterility barrier. This could lead to infection risks if the needle is used improperly. Read more at govinfonow.com/recall/67982-cardinal-health-monoject-needles-recall-sterility-risk-from-manufacturing-defect.
Source Summary by GovInfoNow · govinfonow.com/recall/67982-cardinal-health-monoject-needles-recall-sterility-risk-from-manufacturing-defect · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2042-2019
Cite this page
“Cardinal Health Monoject Needles Recall: Sterility Risk from Manufacturing Defect.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67982-cardinal-health-monoject-needles-recall-sterility-risk-from-manufacturing-defect. Based on FDA recall #Z-2042-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2042-2019%22&limit=1).
Why it’s dangerous
The needles have a manufacturing defect in the cartridge component that could compromise the sterility barrier. This means the needles might not be sterile when used, potentially causing infections.
Who’s affected
People who own or use the recalled Monoject needles for medical injections. Those with higher risk include individuals needing frequent injections.
How to tell if you have this one
Check for the item code 8881200664 and lot numbers 905657, 906327, or 906341 on the packaging. The needles are 20 gauge x 1.5 inches.
- Brand
Cardinal Health- Category
Medical device
All 17 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Completed- Distribution
Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
| Recall number | Product, codes & lots |
|---|---|
| Z-2036-2019 | Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011; Lot Number: 904218, 904918, 906329 |
| Z-2037-2019 | Monoject Standard Hypodermic Needle Item code: 8881200029; Lot Number: 904956 |
| Z-2038-2019 | Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037; Lot Number:904212, 905612, 907002 |
| Z-2039-2019 | Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045; Lot Number: 905613 |
| Z-2040-2019 | Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078; Lot Number: 907007 |
| Z-2041-2019 | Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508; Lot Number: 904901 |
| Z-2042-2019 | Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664; Lot Number: 905657, 906327, 906341 |
| Z-2043-2019 | Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456; Lot Number: 909117 |
| Z-2044-2019 | Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498; Lot Number: 905611 |
| Z-2045-2019 | Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522; Lot Number: 905662 |
| Z-2046-2019 | Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548; Lot Number: 904219, 904220, 907710 |
| Z-2047-2019 | Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654; Lot Number: 902108 |
| Z-2048-2019 | Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314; Lot Number: 905659, 905660, 906343 |
| Z-2049-2019 | Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322; Lot Number: 902110, 902111 |
| Z-2050-2019 | Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355; Lot Number: 905617, 905618, 905619, 905620, 907004, 907005 |
| Z-2051-2019 | Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363; Lot Number: 907734 |
| Z-2052-2019 | Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389; Lot Number: 903530 |
What to do — step by step
Check Product Details
Look for the item code 8881200664 and lot numbers 905657, 906327, or 906341 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2042-2019 (April 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2042-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.