FDA (Devices) recall action 70286
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Products without expiration date have the remote potential for minor burn
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CooperSurgical is recalling Infant Heel Gel Warmers and The Infant Heel Warmer because products without expiration dates have a remote potential for minor burns.
CooperSurgical is recalling NovaPlus infant heel warmers because products without expiration dates may cause minor burns.
CooperSurgical is recalling MediChoice Infant Heel Warmers because products without expiration dates have a remote potential for minor burns.
CooperSurgical is recalling Fisher Brand Gel and Liquid Infant Heel Warmers because products without expiration dates pose a remote potential for minor burns.