FDA Medical Device Recalls (openFDA)
INTEGRATED MEDCRAFT LLC: 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.
- Recall number
- Z-2836-2026
- Recalling firm
- INTEGRATED MEDCRAFT LLC
- 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.
- Status
- Open, Classified
- Initiated
- 2026-07-07
- Posted
- 2026-07-31
- Terminated
- not on file
- Reason
- Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
- Root cause
- Component design/selection
- Action
- Firm initially notified customers on June 23, 2026 via email and June 24,2026 via postal mail. Updated letters were sent on July 7, 2026 via email. Customers were instructed to immediately discontinue use of affected product and inspect inventory for affected product. Customers should return affected product to Integrated MedCraft. If the customer has further distributed affected product, they should notify customers who received the product.
- Quantity
- 509 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Lot Numbers: IMC-00000060, IMC-00000066, IMC-00000078, IMC-00000086, IMC-00000092, IMC-00000096, IMC-00000096, IMC-00000097, IMC-00000103, IMC-00000110, IMC-00000125, IMC-00000151, IMC-00000200, IMC-00000201, IMC-00000204, IMC-00000205. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. Lot Numbers: 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154. 2. Size 000, ISO 3.5, light green. Product Code: 1000035. Lot Numbers: 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAE
- Firm FEI
- 3030078769
- Firm city
- East Hampton
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28