Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity
Class I - DangerousWhat Should You Do?
- Check if you have this product: The following product code and lot numbers were affected by this recall: Product Codes: RLZB22 Lot Numbers: 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, ZLLBCR, ZLLBFT, ZLMBCH, ZLMBWD, ZLNBBF, ZLNBGZ, ZMCBDH, ZMDBCH, ZMFBC4, ZMGBBF, ZMGBC1, ZMHBBW, ZMJBHV, ZMKBBH, ZMLBCJ, ZMNBCK, ZNBBD2, ZNFBCC, ZNHBCM, and ZNLBB4. Product Codes: RLZB22D1 Lot Numbers: G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TK21, G4TL1D, G4TM3L, G4TM84, G4TP0W, G4TT4D, G4TU2V, G4TV3T, G4TW6D, G4U17U, G4U75W, G4U795, G4UD6T, G4UF6Y, G4UG4E, G4UH49, G4UH4K, H43A3N, H43C8P, H43E9V, H43J2P, H43N12, H43N42, H43P5U, H43P9C, H43T3F, H43U78, H43V8J, H43X4K, H43Z8Y, H4453N, H44623, H4478W, H44965, H44C9G, H44D8W, H44K3G, H44K9M, H44N0X, H44R1Y, H44R4U, H44T9D, H44V39, H44W6H, H44Y24, H44Z0Y, J4A04D, J4A11V, J4A274, J4A668, J4A81X, J4A96M, J4AC6L, J4AE3P, J4AH2Z, J4AK89, J4AN34, J4AU9R, J4AW1Y, J4C35K, J4C76E, J4CE9V, K4C518, K4CE4L, K4CT8W, K4D17T, and K4D45Y. Product Codes: RLZB22DG1 Lot Numbers: G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V, G4U184, G4U734, G4UD77, G4UF9V, G4UH6P, H43A3P, H43C8R, H43G7Y, H43T3K, H43U7E, H43X1G, H43Z5Y, H44645, H44H9M, H44K2T, H44L44, H44V3A, H44W6G, H44Y25, H44Z0X, H44Z3N, J4A48K, J4AA11, J4AL00, J4AR9K, and K4CE6X . Product Codes: RLZB22DGT Lot Numbers: G4U323, J4AY55, and K4C663. Product Codes: RLZB22DT Lot Numbers: G4UD92, H44D1Y, J4AY72, and K4C666. Product Codes: RLZB22T Lot Numbers: G4RE82
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ethicon Endo-Surgery Inc
- Reason for Recall:
- During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity
Product Codes/Lot Numbers:
The following product code and lot numbers were affected by this recall: Product Codes: RLZB22 Lot Numbers: 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, ZLLBCR, ZLLBFT, ZLMBCH, ZLMBWD, ZLNBBF, ZLNBGZ, ZMCBDH, ZMDBCH, ZMFBC4, ZMGBBF, ZMGBC1, ZMHBBW, ZMJBHV, ZMKBBH, ZMLBCJ, ZMNBCK, ZNBBD2, ZNFBCC, ZNHBCM, and ZNLBB4. Product Codes: RLZB22D1 Lot Numbers: G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TK21, G4TL1D, G4TM3L, G4TM84, G4TP0W, G4TT4D, G4TU2V, G4TV3T, G4TW6D, G4U17U, G4U75W, G4U795, G4UD6T, G4UF6Y, G4UG4E, G4UH49, G4UH4K, H43A3N, H43C8P, H43E9V, H43J2P, H43N12, H43N42, H43P5U, H43P9C, H43T3F, H43U78, H43V8J, H43X4K, H43Z8Y, H4453N, H44623, H4478W, H44965, H44C9G, H44D8W, H44K3G, H44K9M, H44N0X, H44R1Y, H44R4U, H44T9D, H44V39, H44W6H, H44Y24, H44Z0Y, J4A04D, J4A11V, J4A274, J4A668, J4A81X, J4A96M, J4AC6L, J4AE3P, J4AH2Z, J4AK89, J4AN34, J4AU9R, J4AW1Y, J4C35K, J4C76E, J4CE9V, K4C518, K4CE4L, K4CT8W, K4D17T, and K4D45Y. Product Codes: RLZB22DG1 Lot Numbers: G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V, G4U184, G4U734, G4UD77, G4UF9V, G4UH6P, H43A3P, H43C8R, H43G7Y, H43T3K, H43U7E, H43X1G, H43Z5Y, H44645, H44H9M, H44K2T, H44L44, H44V3A, H44W6G, H44Y25, H44Z0X, H44Z3N, J4A48K, J4AA11, J4AL00, J4AR9K, and K4CE6X . Product Codes: RLZB22DGT Lot Numbers: G4U323, J4AY55, and K4C663. Product Codes: RLZB22DT Lot Numbers: G4UD92, H44D1Y, J4AY72, and K4C666. Product Codes: RLZB22T Lot Numbers: G4RE82
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0149-2014
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