Pintler Medical Recalls 24 Warming Pads Due to Malfunction
Pintler Medical LLC is recalling 24 warming pads used in operating rooms because they malfunction. The affected units were distributed to facilities in Wisconsin.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states the hazard is a 'malfunction' without reporting any specific injuries, illnesses, or deaths. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Pintler Medical LLC is recalling 24 warming pads that are components of the PINTLER PEAK and PINTLER SUMMIT Heated OR pads. The recall was initiated because the warming pads malfunctioned. These devices are indicated for use in any condition where patient warming is desired, as determined by clinical personnel, in accordance with facility normo-thermia protocols.
The affected units are identified by specific lot and part numbers: Lot 27473 (Part PIN-BH85), Lot 27590 (Part PIN-SKY67-OS), Lot 27544 (Part PIN-LG78-OS), Lot 27634 (Part PIN-SUMMIT), and Lot 27498 (Part PIN-PEDS). The total quantity involved in this recall is 24 units.
The recall is limited to the United States, with distribution specifically to the state of Wisconsin. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the affected lots and parts.
The recalled product
- Product
- A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
- Manufacturer
- Pintler Medical LLC
- Category
- Medical Device — Patient Warming
- Hazard
- Affected units
- 24
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 (5)
- Lot Number 27473 Quantity in lots 12 Part Number PIN-BH85
- Lot Number 27590 Quantity in lots 6 Part Number PIN-SKY67-OS
- Lot Number 27544 Quantity in lots 2 Part Number PIN-LG78-OS
- Lot Number 27634 Quantity in lots 3 Part Number PIN-SUMMIT
- and Lot Number 27498 Quantity in lots 1 Part Number PIN-PEDS
Distribution
Distributed in 1 state:
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