Agency classClass IIOur severity:High FDA (Devices)·Z-0155-2022·Announced 2021-10-27

medfusion Stopcock devices recalled due to sterility assurance deficiency

Smiths Medical is recalling over 933,000 medfusion Stopcock medical devices internationally due to lack of sterility assurance. The devices may not meet required sterility standards.

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 recall involving a medical device with a significant sterility assurance defect. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed. Per the severity rubric, sterility-assurance defects without reported illness are classified as High severity.

Plain-English summary

Smiths Medical ASD Inc. is recalling 933,518 medfusion Stopcock medical devices (1-way and 4-way models) due to lack of sterility assurance. These devices are components used in patient infusion systems.

The affected devices were distributed internationally to healthcare facilities in Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland. Specific model numbers and serial numbers are listed in the FDA recall notice.

The devices may not meet required sterility standards. Sterility assurance is critical for medical devices used in patient care, and the affected units may pose a risk if used without verification of their sterility.

The recalled product

Product: medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p.…
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Infusion System Component
Hazard: sterility-assurance
microbial-contamination
Affected units: 933,518

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 (20)

a. 081-101BE
Serial Numbers: 1570340901
1570344401
1570344402 b. 081-101GE
Serial Numbers: 1570343301 c. 081-101GEE
Serial Numbers: 1470293701
1570343401 d. 081-101NE
Serial Numbers: 1570323801
1570341001
1570342701
1570344101
1660688101
1670354301 e. 081-102NE
Serial Numbers: 1660636701 f. 081-102RE
Serial Numbers: 1660636601 g. 089-101E
Serial Numbers: 1570316801
1570342601
1570344601
1660670001
1670347801

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Smiths Medical ASD Inc.

See all →

Severe
CADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
Severe
CADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
Critical
CADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
Critical
CADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
Critical
CADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14

Same hazard · sterility assurance