Lifeline CPR Rescue Kits Recalled for Prescription-Only Mask Component
Lifeline First Aid LLC is recalling CPR rescue kits because the included CPR shield mask is cleared only for prescription use, not over-the-counter.
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, but the source text describes a regulatory clearance issue (prescription vs. OTC) rather than a physical defect or reported illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Lifeline First Aid LLC is recalling specific CPR rescue kits and first aid kits because they contain a CPR Shield with One Way Valve and Barrier Filter. The FDA states that this specific mask component is cleared only for prescription use and is not cleared for over-the-counter (OTC) use.
The recall affects Item #4042, Item #4043, and Item #4037. The affected units were distributed in Arizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Utah, Virginia, Washington, and Wisconsin, as well as in New Zealand.
Consumers should stop using the recalled kits and contact Lifeline First Aid LLC for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red…
- Manufacturer
- Lifeline First Aid LLC
- Category
- Medical Device — First Aid / CPR
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 (15)
- 3/15 101546
- 6/15 101682
- 7/15 101804
- 1/16 101812
- 1/16 102032
- 5/16 102109
- 5/16 102098
- 5/17 102130
- 5/16 102296
- 10/16 102317
- 10/16 102295
- 10/16 102372
- 1/17 102638
- 1/17 102694
- 8/17
Distribution
Part of a larger recall action
This product is one of 2 recalled by Lifeline First Aid LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Lifeline First Aid LLC
See all →- ModerateCadillac First Aid Kit Recalled for Prescription-Only CPR Mask
FDA (Devices) · 2016-07-13
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