Reported Nov 25, 2015 · Terminated

HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated…

Ethicon Endo-Surgery Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Blue Ash, OH · 45242-2803

Is this the product you have?

  • 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.
Lot codes and dates

663 of 663 products

Products covered by this recall
Model / numberProduct as published
HARH23Batch # L90K2V, Exp Date 2019-02
Batch # L90K2W, Exp Date 2019-02
Batch # L90K2X, Exp Date 2019-02
Batch # L90V6P, Exp Date 2019-03
Batch #, L9109W, Exp Date, 2019-03
Batch #, L91739, Exp Date, 2019-04
Batch #, L91F3X, Exp Date, 2019-05
Batch #, L91H6F, Exp Date, 2019-05
Batch #, L91M6D, Exp Date, 2019-06
Batch #, L91W4Z, Exp Date, 2019-06
Batch #, L91Z2W, Exp Date, 2019-07
Batch #, L92002, Exp Date, 2019-07
Batch #, L9214D, Exp Date, 2019-07
Batch #, L92194, Exp Date, 2019-07
Batch #, L92673, Exp Date, 2019-08
Batch #, L92E3H, Exp Date, 2019-08
Batch #, L92G7W, Exp Date, 2019-09
Batch #, L92L5R, Exp Date, 2019-09
Batch #, L92L8T, Exp Date, 2019-09
Batch #, L92R3H, Exp Date, 2019-09
Amount recalled
441,490 pieces

Where it was sold

Why it was recalled

Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 1, 2016 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.