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The Food and Drug Administration (FDA) informs the public and all concerned healthcare professionals that Johnson & Johnson Philippines, Inc. has voluntarily recalled specific lots of HARMONIC ACE® Laparoscopic 5mm Diameter Shears + Adaptive Tissue Technology (Specific Lots only for Codes HAR23 and HAR36), with the following impacted lot numbers:



HARMONIC ACE®+ Shears with Adaptive Tissue Technology

(23CM Length)

HAR23 P9125C P93W8A P94A93 P94H9V
P93T5J P93Y4A P94A94 P94J28
P93T5K P93Z4X P94C8R
P93V06 P93Z96 P94E6U
P93W0A P9400F P94G1W
P93W4Y P9409V P94H32
HARMONIC ACE®+ Shears with Adaptive Tissue Technology

(36CM Length)

HAR36 N93923 P93M6P P93U5N P94C47
N9392K P93M6T P93U90 P94C5R
P9129W P93N00 P93U91 P94C8T
P91394 P93N01 P93V02 P94D0M
P9139N P93N3X P93V03 P94D0P
P9144R P93N3Y P93V0V P94D3J
P9148K P93N5A P93V57 P94D3K
P9149J P93N7H P93V5T P94D5G
P9168K P93P09 P93W9R P94D9K
P9173R P93P26 P93W9X P94E1Z
P9174K P93P2E P93X2G P94E20
P91795 P93P7G P93X2W P94E3Z
P91C51 P93P7H P93X2X P94E8W
P91C83 P93R0Z P93X85 P94F1M
P91F2X P93R10 P93X98 P94F3A
P91K69 P93R4F P93Y47 P94F5T
P91L0H P93R4G P93Y48 P94F6C
P91L1Y P93R56 P93Y8X P94F7L
P91L6E P93R57 P93Z4T P94G1H
P91L6J P93R6U P93Z5X P94G1J
P9396A P93R6V P93Z95 P94H0K
P9396C P93T0X P94015 P94H31
P9399T P93T20 P9414T P94H4V
P93A1L P93T26 P94A5K P94H8J
P93L47 P93T9L P94A6A
P93L76 P93U0P P94C10
P93M5Y P93U17 P94C11

Ethicon Endo-Surgery, LLC (“Ethicon”), the manufacturer of the above-mentioned products confirmed that some devices contained in theses lots may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.


Based on their medical assessment concluded that this situation may cause inadvertent mechanical or thermal damage to unintended tissue if the continuous or inadvertent activation occurs when used in operative cases.

Distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product.

For more information and inquiries, please e-mail us at or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

FDA Advisory No. 2018-207