Cardinal Health Recalls Presource Packs with Medtronic Microstream Components
Cardinal Health 200, LLC is recalling 210 Presource Packs containing Medtronic Microstream components due to reports of difficulty disconnecting the adapter, which can cause treatment delays or unintended extubation.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a hazard involving potential respiratory failure, hypoxia, aspiration, or low oxygen saturation due to difficulty disconnecting the adapter. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Cardinal Health 200, LLC is recalling 210 Presource Packs that contain Medtronic Microstream components. The affected products include Intubation Kits, Intubating Bag Kits, and Intubation UH Kits with specific catalog numbers and lot numbers listed in the agency record. The distribution pattern for these kits is currently pending.
The recall was initiated after Medtronic issued an update to the Instructions for Use of the Microstream components due to reports of difficulty in disconnecting the adapter from a patient's endotracheal tube. This issue can result in a delay to treatment and unintended extubation. The source notes that the potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.
The source does not report any specific illnesses, injuries, or deaths associated with this recall. Healthcare providers and consumers should check their inventory for the specific catalog numbers and lot numbers identified in the recall notice and follow instructions from the recalling firm or the FDA regarding the return or disposal of these products.
The recalled product
- Product
- Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336608G
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Intubation Kits
- Affected units
- 210
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
Same hazard · unintended extubation
See all →- HighMicrostream CO2 sampling lines recalled for difficult adapter disconnection
FDA (Devices) · 2025-03-26
- HighCO2 Sampling Lines May Fail to Disconnect During Neonatal Care
FDA (Devices) · 2025-03-26
- HighMicrostream Neonatal-Infant CO2 Filter Line May Be Difficult to Disconnect
FDA (Devices) · 2025-03-26
Similar recalls
- HighCardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-01-22
- HighCardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2025-01-22
- HighCardinal Health Presource Aneurysm Packs recalled for potential endotoxin contamination
FDA (Devices) · 2025-01-22
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighCardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-02-19
- HighCardinal Health Laryngoscopy Presource Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2025-01-22