Ethicon Endo-Surgery Inc: ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969 The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.

Recall number

Z-3187-2011

Recalling firm

Ethicon Endo-Surgery Inc

Product

ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969 The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.

Status

Terminated

Initiated

2011-07-29

Posted

2011-09-12

Terminated

2013-02-15

Reason

Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the sterility of the device.

Root cause

Packaging

Action

Ethicon Endo-Surgery Inc sent an URGENT DEVICE RECALL letter dated August 11, 2011 to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. Fill out the Business Reply Form and fax it to 1-866-853-2802 if they have any of the affected product. To ensure adequate identification of the return product at their facility customers should complete the Customer Purchase Order Field on the Business Reply Form. For any questions regarding this recall call 1-866-708-2330 and reference Event 2471. For clinical or product support call 1-800-USE-ENDO, option 6, or contact your local sales representative.

Quantity

27,582 instruments

Distribution

Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, GREECE, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, POLAND, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, THAILAND and UNITED ARAB EMIRATES

Lot, serial or model codes

Model # CTS45 Lot # F4PD36, Exp Date Jul-2014; Lot # F4PD9U, Exp Date Jul-2014; Lot # F4PG0X, Exp Date Aug-2014; Lot #, F4PG42, Exp Date Aug-2014; Lot # F4PG92, Exp Date Aug-2014; Lot # F4PH1N, Exp Date Aug-2014; Lot # F4PH4N, Exp Date Aug-2014; Lot # F4PJ4U, Exp Date Aug-2014; Lot # F4PK4W, Exp Date Aug-2014; Lot # F4PM4R, Exp Date Sep-2014; Lot # F4PM61, Exp Date Sep-2014; Lot # F4PN2E, Exp Date Sep-2014; Lot # F4PN8Z, Exp Date Sep-2014; Lot # F4PP1A, Exp Date Sep-2014; Lot # F4PP9F, Exp Date Sep-2014; Lot # F4PR1V, Exp Date Sep-2014; Lot # F4PU0Y, Exp Date Sep-2014; Lot # F4PU6Y, Exp Date Sep-2014; Lot # F4PV1E, Exp Date Oct-2014; Lot # F4PW2Z, Exp Date Oct-2014; Lot # F4PX14, Exp Date Oct-2014; Lot # F4PX5J, Exp Date Oct-2014; Lot # F4PX81, Exp Date Oct-2014; Lot # F4PY36, Exp Date Oct-2014; Lot # F4PY9W, Exp Date Oct-2014; Lot # F4PZ7L, Exp Date Oct-2014; Lot # F4PZ9H, Exp Date Oct-2014; Lot # F4R11D, Exp Date Nov-2014; Lot # F4R14L, Exp Date Nov-2014; Lot # F4R172, Exp Date Nov-2014; Lot # F4R213, Exp Date Nov-2014; Lot # F4R299, Exp Date Nov-2014; Lot # F4R31F, Exp Date Nov-2014; Lot # F4R435, Exp Date Nov-2014; Lot # F4R45U, Exp Date Nov-2014; Lot # G4R54T, Exp Date Dec-2014; Lot # G4R81J, Exp Date Dec-2014; Lot # G4R823, Exp Date Dec-2014; Lot # G4R971, Exp Date Dec-2014; Lot # G4R97A, Exp Date Dec-2014; Lot # G4R99A, Exp Date Dec-2014; Lot # G4RD0H, Exp Date Jan-2015; Lot # G4RD6P, Exp Date Jan-2015; Lot # G4RE6K, Exp Date Jan-2015; Lot # G4RG45, Exp Date Jan-2015; Lot # G4RG7C, Exp Date Jan-2015; Lot # G4RH07, Exp Date Jan-2015; Lot # G4RH1E, Exp Date Jan-2015; Lot # G4RL49, Exp Date Feb-2015; Lot # G4RM0M, Exp Date Feb-2015; Lot # G4RN6U, Exp Date Feb-2015; Lot # G4RN81, Exp Date Feb-2015; Lot # G4RP03, Exp Date Feb-2015; Lot # G4RP4M, Exp Date Feb-2015; Lot # G4RP8C, Exp Date Feb-2015; Lot # G4RR9N, Exp Date Feb-2015; Lot # G4RT2F, Exp Date Feb-2015; Lot # G4RT7H, Exp Date Feb-2015; Lot # G4RU9U, Exp Date Mar-2015; Lot # G4RV45, Exp Date Mar-2015; Lot # G4RV6G, Exp Date Mar-2015; Lot # G4RV95, Exp Date Mar-2015; Lot # G4RW0J, Exp Date Mar-2015; Lot # G4RX6X, Exp Date Mar-2015; Lot # G4RY1G, Exp Date Mar-2015; Lot # G4RY2D, Exp Date Mar-2015; Lot # G4RY4N, Exp Date Mar-2015; Lot # G4RZ1U, Exp Date Mar-2015; Lot # G4T04U, Exp Date Apr-2015; Lot # G4T099, Exp Date Apr-2015; Lot # G4T12L, Exp Date Apr-2015; Lot # G4T159, Exp Date Apr-2015; Lot # G4T39L, Exp Date Apr-2015; Lot # G4T43Y, Exp Date Apr-2015; Lot # G4T48N, Exp Date Apr-2015; Lot # G4T553, Exp Date Apr-2015; Lot # G4T59H, Exp Date Apr-2015; Lot # G4T86K, Exp Date May-2015; Lot # G4T92W, Exp Date May-2015; Lot # G4T96N, Exp Date May-2015; Lot # G4TA3E, Exp Date May-2015; Lot # G4TC5W, Exp Date May-2015; Lot # G4TC82, Exp Date May-2015; Lot # G4TE91, Exp Date Jun-2015; Lot # G4TG0U, Exp Date Jun-2015; Lot # G4TK3C, Exp Date Jun-2015; Lot # G4TK5X, Exp Date Jun-2015; Lot # G4TL66, Exp Date Jul-2015; Lot # G4TL6N, Exp Date Jul-2015; Lot # G4TM1L, Exp Date Jul-2015; Lot # G4TN19, Exp Date Jul-2015; Lot # G4TN5F, Exp Date Jul-2015; Lot # G4TP0Y, Exp Date Jul-2015; Lot # G4TP51, Exp Date Jul-2015; Lot # G4TP88, Exp Date Jul-2015; Lot # G4TR5K, Exp Date Jul-2015 Lot # G4TR9T, Exp Date Jul-2015; Lot # G4TT8Z, Exp Date Jul-2015; Lot # G4TU1G, Exp Date Aug-2015; Lot # G4TU1J, Exp Date Aug-2015; Lot # G4TV44, Exp Date Aug-2015; Lot # G4TX08, Exp Date Aug-2015; Lot # G4TX3H, Exp Date Aug-2015; Lot # G4TZ93, Exp Date Aug-2015; Lot # G4U020, Exp Date Aug-2015; Lot # G4U10D, Exp Date Sep-2015; Lot # G4U13F, Exp Date Sep-2015; Lot # G4U19A, Exp Date Sep-2015; Lot # G4U22Z, Exp Date Sep-2015; Lot # G4U28H, Exp Date Sep-2015; Lot # G4U51C, Exp Date Sep-2015; Lot # G4U62P, Exp Date Sep-2015; Lot # G4U62V, Exp Date Sep-2015; Lot # G4U83X, Exp Date Oct-2015; Lot # G4U91N, Exp Date Oct-2015; Lot # G4U94C, Exp Date Oct-2015; Lot # G4UA7G, Exp Date Oct-2015; Lot # G4UC07, Exp Date Oct-2015; Lot # G4UC4D, Exp Date Oct-2015; Lot # G4UC88, Exp Date Oct-2015; Lot # G4UD43, Exp Date Oct-2015; Lot # G4UD5C, Exp Date Oct-2015; Lot # G4UG3F, Exp Date Nov-2015; Lot # G4UG3J, Exp Date Nov-2015; Lot # G4UG82, Exp Date Nov-2015; Lot # G4UH9L, Exp Date Nov-2015; Lot # H4315X, Exp Date Dec-2015; Lot # H4317R, Exp Date Dec-2015; Lot # H4320H, Exp Date Dec-2015; Lot # H43303, Exp Date Dec-2015; Lot # H43369, Exp Date Dec-2015; Lot # H43409, Exp Date Dec-2015; Lot # H43436, Exp Date Dec-2015; Lot # H4351F, Exp Date Dec-2015; Lot # H43914, Exp Date Jan-2016; Lot # H43966, Exp Date Jan-2016; Lot # H43985, Exp Date Jan-2016; Lot # H43A2A, Exp Date Jan-2016; Lot # H43A4W, Exp Date Jan-2016; Lot # H43C68, Exp Date Jan-2016; Lot # H43E38, Exp DateFeb-2016; Lot # H43F4A, Exp Date Feb-2016; Lot # H43F6N, Exp Date Feb-2016; Lot # H43H3M, Exp Date Feb-2016; Lot # H43H64, Exp Date Feb-2016; Lot # H43H8J, Exp Date Feb-2016; Lot # H43J4N, Exp Date Feb-2016; Lot # H43M40, Exp Date Mar-2016; Lot # H43N4D, Exp Date Mar-2016; Lot # H43N5P, Exp Date Mar-2016; Lot # H43P11, Exp Date Mar-2016; Lot # H43R8Y, Exp Date Apr-2016; Lot # H43T5E, Exp Date Apr-2016; Lot # H43U8W, Exp Date Apr-2016; Lot # H43V5H, Exp Date Apr-2016; Lot # H43W06, Exp Date Apr-2016; Lot # H43W6C, Exp Date Apr-2016; Lot # H4402J, Exp Date May-2016; Lot # H4404X, Exp Date May-2016; Lot # H44303, Exp Date May-2016; Lot # H44369, Exp Date Jun-2016; Lot # H44604, Exp Date Jun-2016 and Lot # H4465K, Exp Date Jun-2016.   Model # CTS45NK Lot # G4TZ37, Exp Date Aug-2015; Lot # G4UC08, Exp Date Oct-2015; Lot # H43A10, Exp Date Jan-2016 and Lot # H43W25, Exp Date Apr-2016.  Model # 6CB45 Lot # F4PE3Z, Exp Date Aug-2014; Lot # F4PH99, Exp Date Aug-2014; Lot # F4PR04, Exp Date Sep-2014; Lot # F4PX54, Exp Date Oct-2014; Lot # F4R204, Exp Date Nov-2014; Lot # G4R554, Exp Date Dec-2014; Lot # G4RD0F, Exp Date Jan-2015; Lot # G4RF4W, Exp Date Jan-2015; Lot # G4RJ23, Exp Date Jan-2015; Lot # G4RJ4D, Exp Date Jan-2015; Lot # G4RM6R, Exp Date Feb-2015; Lot # G4RR8N, Exp Date Feb-2015; Lot # G4RT26, Exp Date Feb-2015; Lot # G4RV11, Exp Date Mar-2015; Lot # G4RW1U, Exp Date Mar-2015; Lot # G4TJ4J, Exp Date Jun-2015; Lot # G4TN2N, Exp Date Jul-2015; Lot # G4TV1Z, Exp Date Aug-2015; Lot # G4UA7F, Exp Date Oct-2015; Lot # G4UC4C, Exp Date Oct-2015; Lot # H4345P, Exp Date Dec-2015 and Lot # H43L03, Exp Date Mar-2016.  Model # SCB45 Lot # F4PE3E, Exp Date Aug-2014; Lot # F4PL2N, Exp Date Aug-2014; Lot # F4PL31, Exp Date Sep-2014; Lot # F4PU2W, Exp Date Sep-2014 and Lot # F4PV36, Exp Date Oct-2014.  Model # SCG45 Lot # F4PL3M, Exp Date Sep-2014; Lot # F4PU2X, Exp Date Sep-2014; Lot # F4PX78, Exp Date Oct-2014; Lot # G4R72N, Exp Date Dec-2014; Lot # G4RC02, Exp Date Dec-2014; Lot # G4RJ3X, Exp Date Jan-2015; Lot # G4RL3U, Exp Date Feb-2015; Lot # G4RW9M, Exp Date Mar-2015; Lot # G4TC56, Exp Date May-2015; Lot # G4TR5C, Exp Date Jul-2015; Lot # G4UD5R, Exp Date Oct-2015; Lot # H43753, Exp Date Jan-2016; Lot # H43E0M, Exp Date Feb-2016 and Lot # H43L83, Exp Date Mar-2016.  Model # SCW45 Lot # F4PD3H, Exp Date Jul-2014; Lot # F4PE5V, Exp Date Aug-2014; Lot # F4PF5T, Exp Date Aug-2014; Lot # F4PL3P, Exp Date Sep-2014; Lot # F4PM1H, Exp Date Sep-2014; Lot # F4PU40, Exp Date Sep-2014; Lot # F4PV44, Exp Date Oct-2014; Lot # F4PW81, Exp Date Oct-2014; Lot # F4R15T, Exp Date Nov-2014; Lot # F4R27D, Exp Date Nov-2014; Lot # F4R352, Exp Date Nov-2014; Lot # G4R69T, Exp Date Dec-2014; Lot # G4R809, Exp Date Dec-2014; Lot # G4RC03, Exp Date Dec-2014; Lot # G4RF2X, Exp Date Jan-2015; Lot # G4RJ4K, Exp Date Jan-2015; Lot # G4RL44, Exp Date Feb-2015; Lot # G4RM75, Exp Date Feb-2015; Lot # G4RP7N, Exp Date Feb-2015; Lot # G4RU54, Exp Date Mar-2015; Lot # G4RX1E, Exp Date Mar-2015; Lot # G4RX62, Exp Date Mar-2015; Lot # G4T14R, Exp Date Apr-2015; Lot # G4T63F, Exp Date Apr-2015; Lot # G4TA7E, Exp Date May-2015; Lot # G4TF2K, Exp Date Jun-2015; Lot # G4TM93, Exp Date Jul-2015; Lot # G4TX42, Exp Date Aug-2015; Lot # G4U04J, Exp Date Sep-2015; Lot # G4U164, Exp Date Sep-2015; Lot # G4U74G, Exp Date Oct-2015; Lot # G4UA6K, Exp Date Oct-2015; Lot # H4305X, Exp Date Dec-2015; Lot # H4324F, Exp Date Dec-2015; Lot # H4329P, Exp Date Dec-2015; Lot # H43755, Exp Date Jan-2016; Lot # H43C2U, Exp Date Jan-2016; Lot # H43H0K, Exp Date Feb-2016; Lot # H43M8E, Exp Date Mar-2016; Lot # H43R6T, Exp Date Apr-2016 and Lot # H4406Z, Exp Date May-2016.

510(k) numbers

["K020779","K061156","K070887"]

PMA numbers

not on file

Product code

GDW

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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