DeviceSignal · Recall classified
INTEGRATED MEDCRAFT LLC
FDA classified a device recall on 2026-07-31 · Class II · Z-2836-2026
EventRecall classified
Effective2026-07-31
ClassificationClass II
On 2026-07-31 the FDA classified a device recall from INTEGRATED MEDCRAFT LLC as Class II. Product: FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002…. Recall Z-2836-2026. The firm initiated it on 2026-07-07. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2836-2026
- Classification
- Class II
- Classified on
- 2026-07-31
- Initiated on
- 2026-07-07
- Firm
- INTEGRATED MEDCRAFT LLC
- Reason
- Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
- Product
- FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2836-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
444392a323f1d71070a2f4c3636fefdf1a5161341a1c70b231982a7bbdf3bff2- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)