Smiths Medical Recalls Intermed 350 ml Sterile Water Humidifiers
Smiths Medical is recalling Intermed 350 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves potential exposure to infectious agents, which is a significant health risk.
Plain-English summary
Smiths Medical Company is recalling Intermed 350 ml Sterile Water Humidifiers with 5psi adapters. The recall is due to a lack of sterility assurance caused by leaking containers, which could lead to exposure to infectious agents.
The affected units were distributed worldwide, including the United States, Canada, and several countries in Europe and South America. Specific lot numbers involved in the recall are A457, A597, B157, B236, Z589, Z655, Z656, and Z661.
Healthcare facilities and consumers should stop using these devices immediately and contact Smiths Medical for instructions on return or replacement.
The recalled product
- Product
- Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
- Affected units
- 128,000
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 (8)
- Model # 0352IMJ Lot Numbers: ¿A457
- A597
- B157
- B236
- Z589
- Z655
- Z656
- and Z661
Distribution
Part of a larger recall action
This product is one of 13 recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company 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 13 products in this recall →Related recalls
Same manufacturer · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
See all →- CriticalMedline Prefilled 550 ml Sterile Bags Recalled for Leaking
FDA (Devices) · 2019-02-13
- CriticalSmiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking
FDA (Devices) · 2019-02-13
- CriticalSmiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
FDA (Devices) · 2019-02-13
- SevereMedline Prefilled 350 ml Sterile Solution Recall Due to Leaking
FDA (Devices) · 2019-02-13
- CriticalSmiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
FDA (Devices) · 2019-02-13
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- SevereSmiths Medical Recalls Sterile Eyewash Due to Leaking Containers
FDA (Drugs) · 2018-01-17
- SevereSmiths Medical Recalls Irrisept OR Bottle Assemblies Due to Sterility Risk
FDA (Devices) · 2018-11-28
- HighSmiths Medical Recalls CADD Medication Cassette Reservoirs Due to Leak Risk
FDA (Devices) · 2015-03-25
- HighSmiths Medical Tracheal Tube Introducer Recall Due to Inadequate Disinfection
FDA (Devices) · 2024-12-04
- SevereSterile Water Syringes recalled for lack of sterility assurance
FDA (Devices) · 2023-12-27
- ModerateSmiths Medical Recalls 15mm Double Swivel Connectors Due to Packaging Concerns
FDA (Devices) · 2024-10-30