Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0278-2016·Announced 2015-11-25

Ethicon Harmonic ACE+ 7 Laparoscopic Shears Recalled for Packaging Defect

Ethicon Endo-Surgery is recalling Harmonic ACE+ 7 Laparoscopic Shears because holes in the Tyvek packaging can compromise the sterile barrier.

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 involves a packaging defect that compromises the sterile barrier. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving potential risk without confirmed harm.

Plain-English summary

Ethicon Endo-Surgery Inc is recalling 441,490 pieces of HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis in 23cm, 36cm, and 45cm lengths. The recall was initiated due to complaints of holes in the Tyvek packaging, which can compromise the sterile barrier provided by the packaging.

The affected products were distributed nationwide in the United States, including the District of Columbia and Puerto Rico, as well as in numerous international countries including Aruba, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Ecuador, Hong Kong, India, Japan, Korea, Malaysia, Mexico, Panama, Peru, Philippines, Singapore, Thailand, Taiwan, and Vietnam. The recall covers specific batch numbers with expiration dates ranging from February 2019 to August 2020.

Healthcare providers and facilities should check their inventory for the affected model numbers and batch codes listed in the official recall notice. If the product is found, it should be removed from use and returned to Ethicon Endo-Surgery Inc according to their instructions.

The recalled product

Product: HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Manufacturer: Ethicon Endo-Surgery Inc
Category: Medical Device — Surgical Instruments
Hazard: packaging-defect
sterility-compromise
Affected units: 441,490

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 (20)

Model # HARH23: Batch # L90K2V
Exp Date 2019-02
Batch # L90K2W
Batch # L90K2X
Batch # L90V6P
Exp Date 2019-03
Batch #
L9109W
Exp Date
2019-03
L91739
2019-04
L91F3X
2019-05
L91H6F
L91M6D
2019-06
L91W4Z
L91Z2W
2019-07

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Ethicon Endo-Surgery Inc

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