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    On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code LWQ·June 12, 2015

    LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

    FDA Recall
    Terminated ·Apollo Endosurgery Inc·Product code LTI·August 15, 2014

    ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

    FDA Recall
    Terminated ·Reshape Medical Inc 100 Calle Iglesia San·Product code LTI·October 14, 2016

    REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" trocar. Product Code RLZB32DGT, Lot #: G4RE81, G4RK6N, G4RL6Z, G4T824, G4T98X, G4TN3R, G4TP1A & G4TR4J.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube Product Code RLZB22DG1, Lot #: G4RJ98, G4T42A, G4T88X, G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 30, 2013

    REALIZE Adjustable Gastric Band-C Product Code RLZB32, Lot #: ZJMBP7, ZJMBP8, ZJMBP9, ZJMBRB, ZJNBB6, ZJNBB7, ZJNBB8, ZJNBB9, ZJNBF5, ZJNBGM, ZJNBGN, ZJNBGP, ZJNBGR, ZJNBK4, ZJNBK5, ZJNBNH, ZJPBF3, ZKBBB8, ZKBBB9, ZKBBCB, ZKBBCM, ZKBBGF, ZKBBGG, ZKBBGH, ZKBBJR, ZKBBJT, ZKBBL0, ZKBBL1, ZKBBL2, ZKBBLY, ZKBBLZ, ZKBBMT, ZKBBN0, ZKBBNZ, ZKCBBH, ZKCBBJ, ZKCBC8, ZKCBC9, ZKCBDY, ZKCBHY, ZKCBHZ, ZKCBKK, ZKCBKL, ZKCBKM, ZKDB05, ZKDB06, ZKDB07, ZKDB08, ZKDB0D, ZKDB0F, ZKDB0G, ZKDBLY, ZKDBLZ, ZKDBMC, ZKDBMD, ZKDBMF, ZKDBMG, ZKDBMH, ZKFBB4, ZKFBBB, ZKFBBF, ZKFBC8, ZKFBC9, ZKFBCL, ZKFBCV, ZKFBDD, ZKFBFH, ZKFBFJ, ZKGBBN, ZKGBBP, ZKGBBR, ZKGBCK, ZKGBCL, ZKGBCM, ZKGBDM, ZKGBDN, ZKGBDP, ZKGBFF, ZKHBBC, ZKHBCH, ZKJBC4, ZKJBCK, ZKJBCL, ZKJBDM, ZKJBDN, ZKJBFV, ZKJBG3, ZKJBGK, ZKJBGL, ZKJBHY, ZKJBHZ, ZKKBB2, ZKKBB3, ZKKBBD, ZKKBBF, ZKKBC6, ZKKBC7, ZKKBD2, ZKKBD3, ZKLBBK, ZKLBBL, ZKLBBM, ZKLBC7, ZKLBCB, ZKLBCC, ZKLBCG, ZKLBCH, ZKLBCJ, ZKLBCK, ZKMBBL, ZKMBBM, ZKMBBN, ZKMBBP, ZKMBKJ, ZKMBKK, ZKMBKL, ZKMBKV, ZKMBKW, ZKMBKY, ZKMBKZ, ZKMBMC, ZKMBMD, ZKMBMF, ZKMBMG, ZKMBMH, ZKMBMJ, ZKMBP4, ZKMBP5, ZKMBP6, ZKMBP7, ZKMBRP, ZKNBBJ, ZKNBBK, ZKNBBL, ZKNBCV, ZKNBCW, ZKNBCY, ZKNBFC, ZKNBG0, ZKNBGM, ZKNBGN, ZKNBGP, ZKNBHH, ZKNBHJ, ZLBBBB, ZLBBBK, ZLBBBL, ZLBBCL, ZLBBDP, ZLBBFN, ZLBBFP, ZLCBBD, ZLCBBF, ZLCBC8, ZLCBCF, ZLCBCG, ZLCBFC, ZLCBGC, ZLDBBF, ZLDBBG, ZLDBBH, ZLDBBJ, ZLDBBK, ZLDBC1, ZLDBC2, ZLDBCC, ZLDBCD, ZLDBCF, ZLDBCG, ZLDBDW, ZLDBDY, ZLFBBJ, ZLFBBK, ZLFBBL, ZLFBCN, ZLFBFC, ZLFBFD, ZLFBGN, ZLFBGP, ZLGBCG, ZLGBCH, ZLGBDD, ZLGBF2, ZLGBF3, ZLGBHC, ZLGBHD, ZLHBBM, ZLHBBN, ZLHBDN, ZLHBDW, ZLHBDY, ZLHBF1, ZLJBBC, ZLJBBV, ZLJBCV & ZLJBCW.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB32DT, Lot #: G4RL1U, G4RL9A, G4RM2V, G4RM5T, G4RN6P, G4RP1M, G4RR5G, G4RW0R & G4TR72.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 30, 2013

    REALIZE Adjustable Gastric Band-C with Endoscopic Dissector. Product Code RLZB32D1, Lot #: G4RK0M, G4RL9X, G4RM94, G4RN9G, G4RY2M, G4RY3E, G4RY56, G4T00G, G4T137, G4T15H, G4T202, G4T224, G4T26M, G4T27Z, G4T31N, G4T31V, G4T34N, G4T385, G4T42F, G4T43U, G4T52W, G4T56F, G4T68L, G4T74D, G4T87X, G4T95Y, G4T992, G4TA5Y, G4TA8W, G4TC20, G4TC48, G4TD1C, G4TD20, G4TE10, G4TE17, G4TE7M, G4TE87, G4TE9Z, G4TF0C, G4TF7A, G4TF9M, G4TG25, G4TG5A, G4TH1V, G4TH48, G4TJ3F, G4TJ70, G4TK18, G4TK1K, G4TK69, G4TK6G, G4TK6T, G4TK90, G4TK9D, G4TL1U, G4TL21, G4TL4C, G4TL58, G4TL6Z, G4TL79, G4TL7H, G4TL7V, G4TM2M, G4TM5K, G4TM5N, G4TM66, G4TM6N, G4TM8A, G4TN16, G4TN86, G4TP15, G4TP39, G4TP3N, G4TP6U, G4TP77, G4TP93, G4TP9K, G4TR22, G4TR4R, G4TR5E, G4TV69, G4TV6N, G4TW45, G4TW67, G4TX6A, G4TX8C & G4TY13.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    REALIZE Injection Port and Applier. Product Code RLZPT2, Lot #: ZHLBCG, ZHPBB8, ZJBBBD, ZJBBBY, ZJCBB0, ZJCBBH, ZJCBDR, ZJJBMT, ZJKBCY, ZJMBPB, ZJNBB4, ZJNBBJ, ZJPBB5, ZKBBCJ, ZKBBGP, ZKBBLM, ZKCBDZ, ZKCBJH, ZKDBK9, ZKDBM2, ZKDBMT, ZKFBC6, ZKFBCW, ZKFBCZ, ZKFBDF, ZKFBFK, ZKMBKR, ZKMBN1, ZKMBP2, ZKNBBF, ZKNBFB, ZKNBHG, ZLCBC7, ZLCBG9, ZLDBBD, ZLDBDZ, ZLFBCJ, ZLFBGR, ZLGBCB, ZLGBDG, ZLGBHF, ZLHBF3 & ZLJBD1.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot Number: 9L01N 20 gauge, 51 mm (2 in.) length non-coring deflected tip (Huber) needle, used with the LAP-BAND System for band adjustment.

    FDA Recall
    Terminated ·Allergan·Product code LTI·March 21, 2011

    Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed laparoscopically around the stomach, creating a small pouch or stoma, thereby limiting food consumption. The band can be inflated or deflated with saline, through the access port, depending on patient needs and progress. The Lap-Band access port is a low-profile cylindrical port attached to kink-resistant tubing . The port is implanted subcutaneously or in the rectus muscle and can be penetrated in its silicone septum by a non-coring needle to inject or remove saline into or from the band. The kink-resistant tubing connects the access port to the band.

    FDA Recall
    Terminated ·Apollo Endosurgery Inc·Product code LTI·November 22, 2017

    REALIZE Adjustable Gastric Band, Injection Port and Applier Product Code: RLZB22, RLZB22D, RLZB22DG Lot # ZHLBBB, ZHLBBC, ZHLBBD, ZHLBBF, ZHLBBG, ZHLBCM, ZHNBC3, ZHPBBV, ZHPBBY, ZJBBB1, ZJBBB2, ZJBBB3, ZJBBBG, ZJBBBH, ZJBBBK, ZJBBCF, ZJBBCG, ZJBBCH, ZJBBCJ, ZJBBD6, ZJBBD7, ZJBBD8, ZJBBD9, ZJBBDH, ZJBBDJ, ZJBBDK, ZJBBFB, ZJBBFC, ZJCBBT, ZJCBBV, ZJCBBW, ZJCBDL, ZJCBDM, ZJCBDN, ZJDBBL, ZJDBDY, ZJFBBB, ZJFBBC, ZJFBBD, ZJFBDC, ZJFBDD, ZJFBF0, ZJFBF1, ZJFBF2, ZJFBKH, ZJFBMK, ZJGBCC, ZJGBCD, ZJGBGM, ZJGBHJ, ZJGBHK, ZJGBTT, ZJHBCD, ZJHBCF, ZJHBCG, ZJHBF5, ZJHBF6, ZJHBF7, ZJHBK8, ZJHBK9, ZJHBLB, ZJHBLC, ZJHBLD, ZJHBLF, ZJJBC4, ZJJBC5, ZJJBC6, ZJJBF9, ZJJBGB, ZJJBGC, ZJJBHM, ZJJBHN, ZJJBHP, ZJJBHR, ZJJBLK, ZJJBLL, ZJJBNV, ZJJBNW, ZJKBBB, ZJKBBC, ZJKBBD, ZJKBC2, ZJKBC3, ZJKBC4, ZJKBHD, ZJKBK4, ZJKBK5, ZJKBK6, ZJLBBR, ZJLBBT, ZJLBBV, ZJMBB5, ZJMBCG, ZJMBCH, ZJMBCJ, ZJMBCK, ZJMBCL, ZJMBJC, ZJMBJD, ZJMBJF, ZJPBD1, ZJPBD2, ZJPBFT, ZJPBFV, ZKBBCC, ZKBBCD, ZKBBCF, ZKBBCG, ZKBBGC, ZKBBGD, ZKBBGJ, ZKBBJN, ZKBBNV, ZKBBNW, ZKBBNY, ZKCBBK, ZKCBDD, ZKCBJJ, ZKMBK4, ZKMBKP, ZKNBBB, ZKNBCL, ZLBBCH, ZLBBFJ, ZLBBFL, ZLCBCB, ZLCBD8, ZLDBCZ, ZLDBDM, ZLDBDV, ZLFBF7 & ZLFBFB.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" trocar Product Code RLZB22DGT, Lot #: G4RK0E

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and calibration tube. Product Code RLZB32DG1, Lot #: G4RK2R, G4RN94, G4RW06, G4RY5C, G4T160, G4T26C, G4T31A, G4T402, G4T46F, G4T695, G4T80A, G4T95G, G4TE9K, G4TF7K, G4TJ0A, G4TJ6Z, G4TL16, G4TM2E, G4TM9K, G4TN3J, G4TN7X, G4TP91, G4TT4N, G4TU84, G4TV1X & G4TV7C.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot #: G4RJ90, G4RY0P, G4T15T, G4T289, G4T49Z, G4T52H, G4T861, G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TH28, G4TK21, G4TL1D, G4TM3L, G4TM84, , , G4TP0W, G4TT4D, G4TU2V, G4TV3T & G4TW6D.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and Applier. Product Code BD2XV, Lot #: 1040602, , 1040603, , 10270503, , 11020504, , 11030502, , 11090510, , 11090511, 1090512, 12030502, 12070502, 12070503, 12070504, 12200501, 12200502, 12200503, 12290505, 12290506, 01120603, 01200602, 01260601, 01260602, 01260603, 01260604, 02210605, 02210606, 02210607, 02280622, 02280623, 03080601, 03080602, 03080605, 03220611, 03220612, 05150601, 05150602, 05150603, 05150604, 05300613, 05300614, 06190606, 06190607, 06190608, 06190614, 06190615, 06190616, 06190617, 06190618, 06260601, 07060601, 07100605, 08140607, 08140608, 09050601, 09050602, 09050603, 09050604, 09050605, 09130601, 09130602, 09130603, 09130604, 09130605, 09180602, 09180603, 09180604, 09250602, 10110601, 10110602, 10110603, 20002024, 20002082, 20002185, 20002186, 20002193, 20002438, 20002439, 20002440, 20002441, 20002484, 20002485, 20003152, 20003153, 20003154, 20003155, 20003196, 20003362, 20003363, 20004437, 20004438, 20005244, 20005659, 20006819, 20006921, ZGNB43, ZGNB44, ZGNB45, ZGPBCC, ZGPBCD, ZGPBCJ, ZGPBCK, ZHBBBN, ZHBBBP, ZHBBBT, ZHCBB0, ZHCBB1, ZHCBB2, ZHCBB3, ZHCBB5, ZHCBB6, ZHCBB7, ZHCBB8, ZHCBB9, ZHDBF7, ZHFB76, ZHFB77, ZHFB79, ZHFBBW, ZHFBBY, ZHGBBJ, ZHGBDJ, ZHGBDK, ZHGBDL, ZHHBD6, ZHHBD7, ZHHBD8, ZHHBD9, ZHHBFB, ZHHBFC, ZHJBBJ, ZHJBBK, ZHJBBL, ZHJBBM, ZHJBBN, ZHJBBP, ZHMBDP, ZHNBC1, ZHNBC2, ZHPBBT, ZJBBBF, ZJBBDP, ZJCBB6, ZJCBDP, ZJCBGL, ZJDBBD, ZJDBBF, ZJDBBG, ZJDBBH, ZJDBBJ, ZJDBBK, ZJFBL6, ZJFBML, ZJHBCH, ZJHBK7, ZJJBC3, ZJKBC1, ZJKBHC, ZJKBK2, ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKFBDH, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV & ZLGBG5.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB22DT, Lot #: G4RK31, G4RR27, G4T28C

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    REALIZE Adjustable Gastric Band-C Pak with 15mm XCEL" trocar Product Code RLZB32T, Lot #: G4RK3F, G4RK51, G4RM62, G4RR1P, G4RW4H, G4RZ07, G4T01F, G4T290, G4T299, G4T525 & G4T821.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010