The Recall Desk
HighFDA (Devices)·Z-0147-2025·Announced 2024-10-30

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
Affected units
141,196

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.

Part of a larger recall action

This product is one of 5 recalled by Smiths Medical ASD 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 5 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · packaging integrity

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