Smiths Medical Portex Thermovent 1200 Recalled for Sterile Packaging Seal Issues
Smiths Medical ASD Inc. is recalling the Thermovent 1200 medical device due to uncertainty in sterile packaging seal integrity. Approximately 141,196 units distributed worldwide are affected.
What this means for you
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 an FDA Class II recall of a sterile medical device where packaging seal integrity cannot be assured. The source text does not report any confirmed illnesses or injuries, and the hazard is based on uncertainty rather than confirmed contamination. This fits the High severity category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Thermovent 1200 medical device. Approximately 141,196 units were distributed worldwide. The product is available in multiple configurations: REF 100/582/000, REF 100/582/000JP, and REF 100/582/000JS, with specific lot numbers detailed in the FDA recall notice.
The recall is due to uncertainty in the seal integrity of the sterile packaging used for these devices.
The FDA has classified this as a Class II recall. Affected lot numbers and UDI codes are specified in the FDA recall notice.
The recalled product
- Product
- smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device
- Hazard
- packaging-integrity
- contamination-risk
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) REF 100/582/000: UDI/DI 35019315022405
- Lot Numbers: 4133230
- UDI/DI 35019315010990
- Lot Numbers: 4138707
- UDI/DI 35019315011003
- Lot Numbers: 4144947
- 4147167
- UDI/DI 35019315018156
- Lot Numbers: 4135055
- 4135056
- 4135057
- 4135059
- 4135061
- 4135063
- 4147386
- 4147387
- UDI/DI 35019315022399
- Lot Numbers: 4133228
- 4133229
- UDI/DI 35019315022429
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03