Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears Recalled for Packaging Seal
Medline is recalling 46 units of reprocessed Ethicon Harmonic ACE+7 Shears due to a potential incomplete seal on the packaging tray.
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 the hazard is a packaging defect (incomplete seal) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medline Industries, LP is recalling 46 units of Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears with Advanced Hemostasis. The specific item number is HARH36R, and the devices are 5mm x 36cm. The recall is limited to units with the following lot numbers: 499617, 499843, 500207, 500315, and 507265.
The recall was initiated because of a potential for an incomplete seal on the packaging tray. This defect could compromise the sterility or integrity of the packaging. The affected products were distributed nationwide in the United States.
Healthcare facilities and consumers who have these specific devices should stop using them and contact Medline Industries, LP for further instructions or a replacement. The agency classification for this recall is Class II.
The recalled product
- Product
- Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 46
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 (6)
- Item Number: HARH36R. UDI/DI: 20193489081326 (case)
- 10193489081329 (each). Lot Numbers: 499617
- 499843
- 500207
- 500315
- 507265.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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