Surgical Instrument Shears Recalled Due to Incomplete Packaging Seal
MEDLINE ReNewal Harmonic ACE+7 surgical shears may have incomplete seals on packaging trays. Approximately 18 units were distributed in the United States. Affected products should not be used.
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: This is a Class II recall of surgical instruments with incomplete packaging seals. Although no injuries have been reported, surgical instruments are risk-of-harm products where packaging integrity is critical to prevent patient harm.
Plain-English summary
MEDLINE ReNewal Harmonic ACE+7 Shears with Advanced Hemostasis (Model HARH45R) are subject to a Class II recall. These surgical instruments are designed for use with GEN11 software version 2018-1 and lower.
The recall is due to incomplete seals on the packaging trays of certain units.
Approximately 18 units have been distributed in the United States. The affected products are identified by lot numbers 498739, 498740, 499057, 499143, and 499227.
Healthcare facilities in possession of affected devices should not use them. Contact MEDLINE INDUSTRIES, LP - Northfield for information regarding replacement or return of the recalled products.
The recalled product
- Product
- MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 18
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 (7)
- UDI/DI 10193489081336 (each)
- 20193489081333 (case)
- Lot Numbers: 498739
- 498740
- 499057
- 499143
- 499227
Distribution
Distribution scope not specified by the agency.
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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