FDA · Medical device recall

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook… and 8 more products

Jan. 27, 2009

Date posted by the FDA: Jan. 27, 2009
Status: Terminated
Filed by: Ethicon Endo-Surgery Inc
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
Distribution pattern: 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.

9 products in this recall

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe (Product Code EPS01)

Product: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe (Product Code EPS01)
Quantity: 40 lots totalling 27,480 pieces
Codes and lots: Product Code# EPS01 - Lot # E4K594, Exp Date 2012-12; Lot # E4K67R, Exp Date 2012-12; Lot # E4K93J, Exp Date 2012-12; Lot # E4KC5J, Exp Date 2013-01; Lot # E4KF21, Exp Date 2013-01; Lot # E4KK1M, Exp Date 2013-02; Lot # E4KK7Z, Exp Date 2013-02; Lot # E4KL9T, Exp Date 2013-02; Lot # E4KM4A, Exp Date 2013-02; Lot # E4KP38, Exp Date 2013-02; Lot # E4KT81, Exp Date 2013-03; Lot # E4KU2X, Exp Date 2013-03; Lot # E4KX2D, Exp Date 2013-03; Lot # E4L01C, Exp Date 2013-04; Lot # E4L02M, Exp Date 2013-04; Lot # E4L21T, Exp Date 2013-04; Lot # E4L66N, Exp Date 2013-04; Lot # E4L738, Exp Date 2013-05; Lot # E4L82C, Exp Date 2013-05; Lot # E4LA6P, Exp Date 2013-05; Lot # E4LC88, Exp Date 2013-05; Lot # E4LE62, Exp Date 2013-05; Lot # E4LG4C, Exp Date 2013-06; Lot # E4LJ8W, Exp Date 2013-06; Lot # E4LK99, Exp Date 2013-06; Lot # E4LM57, Exp Date 2013-06; Lot # E4LP5G, Exp Date 2013-07; Lot # E4LU30, Exp Date 2013-07; Lot # E4LV48, Exp Date 2013-07; Lot # E4LX91, Exp Date 2013-07; Lot # E4M068, Exp Date 2013-08; Lot # E4M12K, Exp Date 2013-08; Lot # E4M23T, Exp Date 2013-08; Lot # E4M33W, Exp Date 2013-08; Lot # E4M387, Exp Date 2013-08; Lot # E4M43R, Exp Date 2013-08; Lot # E4M54H, Exp Date 2013-08; Lot # E4M75K, Exp Date 2013-09; Lot # E4M973, Exp Date 2013-09; and Lot # E4MA8R, Exp Date 2013-09.
Recall started: Dec. 9, 2008
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: 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.
Recall number: Z-0655-2009

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

Product: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product Code EPS02)
Quantity: 32 lots, 18,528 pieces
Codes and lots: 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
Recall started: Dec. 9, 2008
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: 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.
Recall number: Z-0656-2009

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe (Product Code EPS03)

Product: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe (Product Code EPS03)
Quantity: 48 (labeled as LLC) lots + 4 (labeled as Inc.) lots, totaling 33,654 pieces
Codes and lots: Product Code EPS03 - Lot # E4K182, Exp. Date 2012-12; Lot # E4K59R, Exp. Date 2012-12; Lot # E4K67T, Exp. Date 2012-12; Lot # E4K81D, Exp. Date 2012-12; Lot # E4K938, Exp. Date 2012-12; Lot # D4JL20, Exp. Date 2012-09; Lot # D4JL21, Exp. Date 2012-09; Lot # D4JL22, Exp. Date 2012-09; Lot # E4KC1M, Exp. Date 2013-01; Lot # E4KF20, Exp. Date 2013-01; Lot # E4KK23, Exp. Date 2013-02; Lot # E4KK6V, Exp. Date 2013-02; Lot # E4KL0N, Exp. Date 2013-02; Lot # E4KR6Y, Exp. Date 2013-03; Lot # E4KV1X, Exp. Date 2013-03; Lot # E4KX2Z, Exp. Date 2013-03; Lot # E4KY5H, Exp. Date 2013-03; Lot # E4L18A, Exp. Date 2013-04; Lot # E4L404, Exp. Date 2013-04; Lot # E4L66M, Exp. Date 2013-04; Lot # E4L69A, Exp. Date 2013-05; Lot # E4L871, Exp. Date 2013-05; Lot # E4LA7Z, Exp. Date 2013-05; Lot # E4LD0T, Exp. Date 2013-05; Lot # E4LF5F, Exp. Date 2013-05; Lot # E4LJ46, Exp. Date 2013-06; Lot # E4LJ4F, Exp. Date 2013-06; Lot # E4LK9C, Exp. Date 2013-06; Lot # E4LN16, Exp. Date 2013-06; Lot # E4LP57, Exp. Date 2013-07; Lot # E4LR66, Exp. Date 2013-07; Lot # E4LT3Y, Exp. Date 2013-07; Lot # E4LU2Z, Exp. Date 2013-07; Lot # E4LV56, Exp. Date 2013-07; Lot # E4M00W, Exp. Date 2013-08; Lot # E4M01X, Exp. Date 2013-08; Lot # E4M120, Exp. Date 2013-08; Lot # E4M20L, Exp. Date 2013-08; Lot # E4M23R, Exp. Date 2013-08; Lot # E4M31A, Exp. Date 2013-08; Lot # E4M376, Exp. Date 2013-08; Lot # E4M39C, Exp. Date 2013-08; Lot # E4M572, Exp. Date 2013-08; Lot # E4M57U, Exp. Date 2013-08; Lot # E4M62M, Exp. Date 2013-08; Lot # E4M914, Exp. Date 2013-09; Lot # E4MA2R, Exp. Date 2013-09; and Lot # E4MD45, Exp. Date 2013-09
Recall started: Dec. 9, 2008
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: 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.
Recall number: Z-0657-2009

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe (Product Code EPS04)

Product: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe (Product Code EPS04)
Quantity: 13 lots, 2,304 pieces
Codes and lots: Product Code EPS04 - Lot # E4KC2J, Exp. Date 2013-01; Lot # E4KG8M, Exp. Date 2013-01; Lot # E4KP8H, Exp. Date 2013-02; Lot # E4KV0T, Exp. Date 2013-03; Lot # E4L030, Exp. Date 2013-04; Lot # E4L892, Exp. Date 2013-05; Lot # E4LD0R, Exp. Date 2013-05; Lot # E4LK7V, Exp. Date 2013-06; Lot # E4LX1D, Exp. Date 2013-07; Lot # E4M072, Exp. Date 2013-08; Lot # E4M28F, Exp. Date 2013-08; Lot # E4M91D, Exp. Date 2013-09; and Lot # E4MA2P, Exp. Date 2013-09
Recall started: Dec. 9, 2008
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: 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.
Recall number: Z-0658-2009

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product Code EPS05)

Product: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product Code EPS05)
Quantity: 21 lots, 5,952 pieces
Codes and lots: 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
Recall started: Dec. 9, 2008
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: 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.
Recall number: Z-0659-2009

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe (Product Code EPS06)

Product: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe (Product Code EPS06)
Quantity: 30 lots, 11,352 pieces
Codes and lots: Product Code EPS06 - Lot # E4K730, Exp. Date 2012-12; Lot # E4K937, Exp. Date 2012-12; Lot # E4KE28, Exp. Date 2013-01; Lot # E4KF4E, Exp. Date 2013-01; Lot # E4KK3D, Exp. Date 2013-02; Lot # E4KK9Z, Exp. Date 2013-02; Lot # E4KT18, Exp. Date 2013-03; Lot # E4KU5A, Exp. Date 2013-03; Lot # E4KW7W, Exp. Date 2013-03; Lot # E4KY71, Exp. Date 2013-03; Lot # E4KZ5L, Exp. Date 2013-03; Lot # E4KZ9G, Exp. Date 2013-04; Lot # E4L189, Exp. Date 2013-04; Lot # E4L41U, Exp. Date 2013-04; Lot # E4L53G, Exp. Date 2013-04; Lot # E4L54M, Exp. Date 2013-04; Lot # E4L891, Exp. Date 2013-05; Lot # E4LA6F, Exp. Date 2013-05; Lot # E4LD1N, Exp. Date 2013-05; Lot # E4LF86, Exp. Date 2013-05; Lot # E4LJ4C, Exp. Date 2013-06; Lot # E4LN1J, Exp. Date 2013-06; Lot # E4LT6C, Exp. Date 2013-07; Lot # E4LU3P, Exp. Date 2013-07; Lot # E4M20H, Exp. Date 2013-08; Lot # E4M338, Exp. Date 2013-08; Lot # E4M457, Exp. Date 2013-08; Lot # E4M54G, Exp. Date 2013-08; Lot # E4M634, Exp. Date 2013-08; and Lot # E4MA4N, Exp. Date 2013-09
Recall started: Dec. 9, 2008
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: 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.
Recall number: Z-0660-2009

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe (Product Code EPS07)

Product: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe (Product Code EPS07)
Quantity: 19 lots, 7,104 pieces
Codes and lots: Product Code EPS07 - Lot # E4KC1V, Exp Date 2013-01; Lot # E4KJ1J, Exp Date 2013-02; Lot # E4KM09, Exp Date 2013-02; Lot # E4KV1N, Exp Date 2013-03; Lot # E4KZ5M, Exp Date 2013-03; Lot # E4L464, Exp Date 2013-04; Lot # E4L664, Exp Date 2013-04; Lot # E4LA0W, Exp Date 2013-05; Lot # E4LC3M, Exp Date 2013-05; Lot # E4LE63, Exp Date 2013-05; Lot # E4LJ89, Exp Date 2013-06; Lot # E4LK9K, Exp Date 2013-06; Lot # E4LR3Y, Exp Date 2013-07; Lot # E4LX68, Exp Date 2013-07; Lot # E4LX88, Exp Date 2013-07; Lot # E4M071, Exp Date 2013-08; Lot # E4M43P, Exp Date 2013-08; Lot # E4M83K, Exp Date 2013-09; and Lot # E4M98Y, Exp Date 2013-09.
Recall started: Dec. 9, 2008
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: 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.
Recall number: Z-0661-2009

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe (Product Code EPS08)

Product: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe (Product Code EPS08)
Quantity: 4 lots, 552 pieces
Codes and lots: Product Code EPS08 - Lot # E4KF22, Exp. Date 2013-01; Lot # E4L088, Exp. Date 2013-04; Lot # E4LR3X, Exp. Date 2013-07; and Lot # E4MD46, Exp. Date 2013-09
Recall started: Dec. 9, 2008
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: 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.
Recall number: Z-0662-2009

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe (Product Code EPS09)

Product: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe (Product Code EPS09)
Quantity: 13 lots, 2,448 pieces
Codes and lots: Product code EPS09 - Lot # E4KC2H, Exp. Date 2013-01; Lot # E4KJ1H, Exp. Date 2013-02; Lot # E4KR73, Exp. Date 2013-03; Lot # E4KW8R, Exp. Date 2013-03; Lot # E4L465, Exp. Date 2013-04; Lot # E4LA5T, Exp. Date 2013-05; Lot # E4LD9H, Exp. Date 2013-05; Lot # E4LF6M, Exp. Date 2013-05; Lot # E4LK7U, Exp. Date 2013-06; Lot # E4LU3N, Exp. Date 2013-07; Lot # E4M33D, Exp. Date 2013-08; Lot # E4M69J, Exp. Date 2013-09; and Lot # E4M83N, Exp. Date 2013-09.
Recall started: Dec. 9, 2008
Device type: Laparoscope, General & Plastic Surgery
Root cause (FDA): Process design
What the company told customers: 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.
Recall number: Z-0663-2009

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0655-2009, Z-0656-2009, Z-0657-2009, Z-0658-2009, Z-0659-2009, Z-0660-2009, Z-0661-2009, Z-0662-2009 and others. The agency record governs; check it and the company before acting.

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