FDA recalls MAC laryngoscope sets due to packaging error
Baxter Healthcare Corporation is recalling MAC laryngoscope devices due to a packaging error. The recall affects 99 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II voluntary precautionary recall with no reported illnesses, injuries, or hospitalization. The hazard is a packaging error without known patient impact, placing this in the 'voluntary precautionary recalls' category per the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling laryngoscope devices due to a packaging error. Three product variants are affected: #1 MAC F/O LARYNGOSCOPE, F/O Laryngoscope Set-MAC, and F/O Laryngoscope Set-MAC W/LED. The recall involves 99 units with lot code 21-056 (Product Codes: 69061, 69696, and 69696-LED).
This is an FDA Class II recall initiated voluntarily by the manufacturer on May 17, 2022. The reason for recall is a packaging error, though the specific nature of the error is not detailed in the recall notice.
The affected devices were distributed worldwide, including throughout the United States and to over 40 countries in Europe, Asia, Africa, South America, and the Middle East. The recall was terminated on May 4, 2026.
The recalled product
- Product
- #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 99
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 (4)
- Product Codes: 69061 (UDI/DI:732094141382)
- 69696 (UDI/DI: 732094141078)
- 69696-LED (UDI/DI: 732094230697)
- Lot code: 21-056
Distribution
Distributed nationwide across the United States.
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