SAGB QuickClose Swedish Adjustable Gastric band

Yes

Non-active implants - special implants

The following product code and lot numbers were affected by this recall: Product Codes: 2200-X Lot Numbers: ZLGBC5, ZLNBCW, ZLNBJC, ZLPBB9, ZMBBBB, ZMCBBC, ZMGBCJ, ZMHBBT, ZMHBCV, ZMLBD0, ZMMBCD, ZMPBBC, ZNCBC6, ZNGBB3, and ZNGBBF.

Gastroenterology-Urology Devices

3

Yes

Worldwide Distribution: USA (nationwide) including the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia; and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.

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

The following product code and lot numbers were affected by this recall: Product Codes: BD2XV Lot Numbers: ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV, ZLGBG5 , ZLJBCL, ZLMBBD, ZLMBYF, ZLNBCH, ZMBBGJ, ZMCBDL, ZMFBCT, ZMGBDF, ZMKBCG, ZNBBBB, and ZNCBBB.

Gastroenterology-Urology Devices

3

Yes

Worldwide Distribution: USA (nationwide) including the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia; and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.

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

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.

Gastroenterology-Urology Devices

3

Yes

Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.

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.