CareFusion Genesis Sterile Containers Fail Sterilization Testing Requirements
Reusable sterilization containers manufactured by Carefusion have not consistently met aerosol challenge testing requirements. 483 units distributed in the US and internationally are being recalled.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where failure to meet sterilization testing requirements could lead to inadequate sterilization and infection risk. Although no illnesses or injuries have been reported, the potential for serious harm is significant in a surgical/medical setting. Per the rubric, this qualifies as a high-risk product without reported injury.
Plain-English summary
The U.S. Food and Drug Administration is recalling Genesis STERRAD Reusable Rigid Sterilization Containers manufactured by Carefusion 2200 Inc. The containers have not consistently met the requirements for aerosol challenge testing, which validates the effectiveness of the sterilization process.
The recalled containers (UDI/DI 10885403019531, all lots) were distributed in the United States and internationally, including to Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, United Kingdom, and United Arab Emirates. A total of 483 units have been identified.
Failure to meet sterilization testing requirements could potentially compromise the containers' ability to ensure proper sterilization of medical instruments and equipment. Healthcare facilities and users should contact Carefusion 2200 Inc for instructions on returning the affected containers or obtaining replacements.
The recalled product
- Product
- CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 483
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI (01) 10885403019531
- ALL LOTS
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 17 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
Same manufacturer · Carefusion 2200 Inc
See all →- HighEndoscopic surgical clamp recalled for defective rotation knob
FDA (Devices) · 2023-08-23
- HighSurgical Clamp Recall: Rotation Knob May Crack or Break
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic Surgical Dissectors Recalled for Potential Rotation Knob Cracking
FDA (Devices) · 2023-08-23
- HighEndoscopic surgical graspers recalled for potential rotation knob failure
FDA (Devices) · 2023-08-23
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- HighGenesis Sterilization Containers Recalled for Shelf-Life Testing Failure
FDA (Devices) · 2023-03-15
- HighCarefusion Vaginal Specula Recalled for Incorrect Labeling and Packaging
FDA (Devices) · 2023-05-03
- HighCarefusion Illinois Needle Aspiration Recall Due to Compromised Sterile Packaging
FDA (Devices) · 2018-04-25
- ModerateJewel Precision Sterilization Container System Recalled for FDA Non-Clearance
FDA (Devices) · 2025-07-02
- HighCarefusion 2200 Manometer Recall Due to Compromised Sterile Packaging Integrity
FDA (Devices) · 2018-04-25
- ModerateCarefusion Recalls Jamshidi Needle Biopsy Devices Due to Packaging Integrity Concerns
FDA (Devices) · 2018-04-25