Ethicon Endo-Surgery Inc: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product Code EPS02)

Recall number

Z-0656-2009

Recalling firm

Ethicon Endo-Surgery Inc

Product

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product Code EPS02)

Status

Terminated

Initiated

2008-12-09

Posted

2009-01-27

Terminated

2010-10-20

Reason

Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens

Root cause

Process design

Action

On 12/9/2008 Ethicon Endo-Surgery sent recall notification letters to their customers instructing them to stop using the product, examine all inventory to determine if they have the affected product on hand and remove the affected products from inventory. They requested that each customer complete the Business Reply Form and fax it back to Stericycle and also return any affected product to Stericycle.

Quantity

32 lots, 18,528 pieces

Distribution

Worldwide distribution: USA, PUERTO RICO, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, DOMINICAN REPUBLIC, EGYPT, ENGLAND, EQUADOR, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, PAKISTAN, PANAMA, POLAND, REPUBLIC OF YEMEN, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, URUGUAY, and VENEZUELA.

Lot, serial or model codes

Product Code EPS02 - Lot # E4K181, Exp. Date 2012-12; Lot # E4K58C, Exp. Date 2012-12; Lot # E4KC5X, Exp. Date 2013-01; Lot # E4KD1P, Exp. Date 2013-01; Lot # E4KF2N, Exp. Date 2013-01; Lot # E4KG70, Exp. Date 2013-01; Lot # E4KK22, Exp. Date 2013-02; Lot # E4KP2F, Exp. Date 2013-02; Lot # E4KV17, Exp. Date 2013-03; Lot # E4KY1A, Exp. Date 2013-03; Lot # E4KY70, Exp. Date 2013-03; Lot # E4L03H, Exp. Date 2013-04; Lot # E4L519, Exp. Date 2013-04; Lot # E4L73Z, Exp. Date 2013-05; Lot # E4L916, Exp. Date 2013-05; Lot # E4LC3K, Exp. Date 2013-05; Lot # E4LD8L, Exp. Date 2013-05; Lot # E4LF60, Exp. Date 2013-05; Lot # E4LG4D, Exp. Date 2013-06; Lot # E4LL7P, Exp. Date 2013-06; Lot # E4LT6E, Exp. Date 2013-07; Lot # E4LX4H, Exp. Date 2013-07; Lot # E4M045, Exp. Date 2013-08; Lot # E4M12L, Exp. Date 2013-08; Lot # E4M27N, Exp. Date 2013-08; Lot # E4M466, Exp. Date 2013-08; Lot # E4M535, Exp. Date 2013-08; Lot # E4M54F, Exp. Date 2013-08; Lot # E4M69H, Exp. Date 2013-09; Lot # E4M838, Exp. Date 2013-09; Lot # E4MA4M, Exp. Date 2013-09; and Lot # E4MC3A, Exp. Date 2013-09

510(k) numbers

["K912492"]

PMA numbers

not on file

Product code

GCJ

Firm FEI

1527736

Firm city

Cincinnati

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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