CareFusion sterilization containers fail aerosol challenge testing
CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The FDA is recalling 510 units to prevent potential sterilization failures.
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: FDA Class II medical device with failed sterilization validation testing represents a risk-of-harm scenario; improper sterilization poses serious infection risk. However, no illnesses or injuries have been reported, keeping this at High rather than Severe per the rubric.
Plain-English summary
CareFusion 2200 Inc is recalling the V.Mueller GENESIS MID-LENGTH CONTAINER (REF CD2-5ST), a reusable rigid sterilization container used for sterilizing surgical instruments. The containers have not consistently met the requirements for aerosol challenge testing, which verifies that sterilization processes are effective.
Sterilization containers that fail aerosol challenge testing may not properly sterilize instruments placed within them. This creates a risk of non-sterile instruments being used in medical procedures, potentially leading to healthcare-associated infections.
The recall affects 510 units with UDI/DI (01) 10885403019142 across all lots. Distribution includes the United States and 17 international locations: 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.
Healthcare facilities using these containers should discontinue use and contact CareFusion 2200 Inc for replacement or return instructions. No illnesses or injuries have been reported as of this recall.
The recalled product
- Product
- CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 510
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) 10885403019142
- 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 Bipolar Forceps Recalled Due to Missing Instructions for Use
FDA (Devices) · 2022-12-14
- HighCarefusion Illinois Needle Aspiration Recall Due to Compromised Sterile Packaging
FDA (Devices) · 2018-04-25
- SevereMedline Recalls Non-Sterile Urinalysis Kit Specimen Containers
FDA (Devices) · 2024-11-20
- HighCarefusion 2200 Manometer Recall Due to Compromised Sterile Packaging Integrity
FDA (Devices) · 2018-04-25