Carefusion Genesis Sterilization Containers Recall: Aerosol Test Failure
Carefusion recalls Genesis STERRAD reusable sterilization containers that failed aerosol challenge testing. These containers may not meet safety standards for sterilization processes.
Recall notice
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Contact the company
What happened, in plain English
Carefusion is recalling Genesis STERRAD reusable sterilization containers because they did not consistently pass aerosol challenge testing. This could mean the containers may not meet safety standards for sterilization processes, potentially affecting medical procedures. Read more at govinfonow.com/recall/60011-carefusion-genesis-sterilization-containers-recall-aerosol-test-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/60011-carefusion-genesis-sterilization-containers-recall-aerosol-test-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0214-2023
Cite this page
“Carefusion Genesis Sterilization Containers Recall: Aerosol Test Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60011-carefusion-genesis-sterilization-containers-recall-aerosol-test-failure. Based on FDA recall #Z-0214-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0214-2023%22&limit=1).
Why it’s dangerous
The containers failed aerosol challenge testing, which checks if they can properly handle sterilization processes. This could mean the containers may not effectively prevent contamination during medical procedures.
Who’s affected
Healthcare facilities using these containers for medical sterilization are likely affected. Patients and staff at facilities using the recalled containers face the highest risk.
How to tell if you have this one
Look for the Carefusion Genesis STERRAD Full-Length Container with dimensions 23 x 12" (58.4 x 30.5cm) and depth 6" (15.2cm). The product code is CD3-6ST with UDI/DI number 10885403019395 across all lots.
- Brand
Carefusion- Product
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF- 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
Ongoing- Distribution
US and Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, UK, United Arab Emirates
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0203-2023 | CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST; UDI/DI (01) 10885403018886, ALL LOTS | 334 units |
| Z-0204-2023 | CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST; UDI/DI (01) 10885403018930, ALL LOTS | 1143 units |
| Z-0205-2023 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST; UDI/DI (01) 10885403018978, ALL LOTS | 493 units |
| Z-0206-2023 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST; UDI/DI (01) 10885403019012, ALL LOTS | 1132 units |
| Z-0207-2023 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST; UDI/DI (01) 10885403019050, ALL LOTS | 259 units |
| Z-0208-2023 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST; UDI/DI (01) 10885403019111, ALL LOTS | 319 units |
| Z-0209-2023 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST; UDI/DI (01) 10885403019142, ALL LOTS | 510 units |
| Z-0210-2023 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST; UDI/DI (01) 10885403019173, ALL LOTS | 265 units |
| Z-0211-2023 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST; UDI/DI (01) 10885403019203, ALL LOTS | 16 units |
| Z-0212-2023 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST; UDI/DI (01) 10885403019319, ALL LOTS | 308 units |
| Z-0213-2023 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST; UDI/DI (01) 10885403019357, ALL LOTS | 451 units |
| Z-0214-2023 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST; UDI/DI (01) 10885403019395, ALL LOTS | 318 units |
| Z-0215-2023 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST; UDI/DI (01) 10885403019432, ALL LOTS | 50 units |
| Z-0216-2023 | CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST; UDI/DI (01) 10885403019500, ALL LOTS | 895 units |
| Z-0217-2023 | CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST; UDI/DI (01) 10885403019531, ALL LOTS | 483 units |
| Z-0218-2023 | CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST; UDI/DI (01) 10885403019562, ALL LOTS | 562 units |
| Z-0219-2023 | CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST; UDI/DI (01) 10885403019593, ALL LOTS | 537 units |
What to do — step by step
Check Product Details
Identify the container by its dimensions (23 x 12" / 58.4 x 30.5cm) and depth (6" / 15.2cm), product code CD3-6ST, and UDI/DI number 10885403019395.
How this recall unfolded
Recall timeline
FDA published this recall 58 days 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-0214-2023 (September 26, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0214-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.