FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery Inc: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product Code EPS05)
- Recall number
- Z-0659-2009
- Recalling firm
- Ethicon Endo-Surgery Inc
- Product
- Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product Code EPS05)
- 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
- 21 lots, 5,952 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 EPS05 - Lot # E4K72Z, Exp. Date 2012-12; Lot # E4K92E, Exp. Date 2012-12; Lot # E4KE29, Exp. Date 2013-01; Lot # E4KH2L, Exp. Date 2013-01; Lot # E4KP2E, Exp. Date 2013-02; Lot # E4KU5K, Exp. Date 2013-03; Lot # E4KX1Y, Exp. Date 2013-03; Lot # E4L03G, Exp. Date 2013-04; Lot # E4L69Y, Exp. Date 2013-05; Lot # E4LA5X, Exp. Date 2013-05; Lot # E4LE64, Exp. Date 2013-05; Lot # E4LF6H, Exp. Date 2013-05; Lot # E4LN1K, Exp. Date 2013-06; Lot # E4LR3W, Exp. Date 2013-07; Lot # E4LU50, Exp. Date 2013-07; Lot # E4M00X, Exp. Date 2013-08; Lot # E4M24N, Exp. Date 2013-08; Lot # E4M506, Exp. Date 2013-08; Lot # E4M62L, Exp. Date 2013-08; Lot # E4M79W, Exp. Date 2013-09; and Lot # E4MA4P, 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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