Teleflex Recalls Rusch Greenlite MAC 1 Tracheal Intubation Devices
Teleflex Medical is recalling Rusch Greenlite MAC 1 devices because some pouches may contain the incorrect product size, specifically MAC 2 instead of MAC 1.
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: The recall is classified as FDA Class II and involves a labeling error where the wrong product size may be dispensed. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teleflex Medical is voluntarily recalling 2,140 units of the Rusch Greenlite MAC 1, Catalog Number 004551001, used during tracheal intubation. The recall is due to a labeling error where pouches labeled as containing the MAC 1 size may instead contain the MAC 2 size.
The affected units are identified by Lot/Serial number 1602312. The recall is limited to the United States. The source text does not report any illnesses or injuries associated with this recall.
Healthcare providers and consumers should stop using the affected devices and contact Teleflex Medical for further instructions or a replacement.
The recalled product
- Product
- Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
- Manufacturer
- Teleflex Medical
- Affected units
- 2,140
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 (1)
- Lot/Serial number: 1602312
Distribution
Distribution scope not specified by the agency.
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