Surgitube Surgical Bandages Recalled for Temperature Exposure During Storage
McKesson is recalling Surgitube surgical bandages distributed between June and September 2021 that may have been exposed to elevated temperatures during storage. The FDA states the temperature exposure is unlikely to cause adverse health effects.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III recall with no reported illnesses or injuries. The FDA explicitly states the temperature deviation is not likely to cause adverse health consequences, and the hazard is theoretical. This is a precautionary recall for potential effectiveness loss.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling five variants of Surgitube surgical bandages and gauze products due to temperature exposure during storage and shipment. The products were distributed nationwide in the United States between June 1, 2021, and September 30, 2021.
The temperature excursions occurred from June through August 2021, prior to delivery. These conditions may have reduced the products' effectiveness. The affected products are Surgitube Bandage Gauze in sizes 1 5/8" (Catalog #GL-219), 2 1" (#GL-220), 4 2 5/8" (#GL-222), and two no-applicator versions measuring 5/8"x50 yards (#GL-241) and 1 1/2"x50 yards (#GL-243).
According to the FDA, while the temperature exposure may have impacted product effectiveness, this specific storage temperature deviation is not likely to cause adverse health consequences. Healthcare facilities and distributors should verify that any remaining inventory was not affected by the identified temperature excursions during the June-August 2021 period.
The recalled product
- Product
- a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2 1" 50YDS Catalog # GL-220. c. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ4 25/8" 50YDS Catalog # GL-222. d.…
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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.
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