Z-2836-2026Class II

FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected...

Name: Z-2836-2026 FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected...
Creator: Integrated Medcraft Llc
Published: 2026-07-07
License: https://open.fda.gov/license/

Integrated Medcraft LLC / initiated 2026-07-07 / Open, Classified / root cause: design

FDA source

INTEGRATED MEDCRAFT LLC began a recall of 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... on 2026-07-07. FDA classified it as Class II and gives the reason as "Devices could potentially contain an occluded or partially occluded Guedel Airway tip". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2836-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-07
Posted: 2026-07-31
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.
Product code: CAE Airway, Oropharyngeal, Anesthesiology
Reason for recall: Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Root cause tag: design
FDA 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 in commerce: 509 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2836-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2836-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31
Z-2837-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)