FDA Devices recall · Reported August 12, 2026
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.
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Integrated Medcraft LLC recalled FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. … - a moderate-severity action.
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. … was recalled by Integrated Medcraft LLC in August 12, 2026. Reason: Devices could potentially contain an occluded or partially occluded Guedel Airway tip.. Check the official notice for the remedy. Verify recall #Z-2836-2026 with the FDA Devices before acting.
The recall
Integrated Medcraft LLC issued this moderate-severity FDA Devices recall-Devices could potentially contain an occluded or partially occluded Guedel Airway tip..
- Moderate
- severity level
- 509 units
- affected scope
- Class II
- classification
- August 12, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2836-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2836-2026) was formally reported on August 12, 2026, with the manufacturer initiating the action on July 7, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Integrated Medcraft LLC is listed as the recalling firm, operating out of East Hampton, CT. Federal records list the affected scope as 509 units.
The documented reason for this recall is: Devices could potentially contain an occluded or partially occluded Guedel Airway tip. Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Reason for recall
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2836-2026 |
| Date reported | August 12, 2026 |
| Date initiated | July 7, 2026 |
| Recalling firm | Integrated Medcraft LLC |
| Firm location | East Hampton, CT |
| Affected scope | 509 units |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2836-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
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Methodology · Corrections · Archive as of August 2026