Ethicon Endo-Surgery Recalls Adjustable Gastric Bands Due to Locking Failure
Ethicon Endo-Surgery Inc is recalling adjustable gastric bands because they failed to meet force-to-lock requirements during aging studies.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure (force to lock) in a surgical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling its Adjustable Gastric Bands, which are intended for use in the surgical treatment of morbid obesity. The recall was initiated after the firm determined during aging studies that the gastric belts were unable to pass the test requirements established for Force to Lock.
The affected products are packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. The recall covers specific product codes and lot numbers, including RLZB22, RLZB22D1, RLZB22DG1, RLZB22DGT, RLZB22DT, and RLZB22T.
The products were distributed worldwide, including nationwide in the United States and in numerous countries across Europe, Asia, the Americas, and the Middle East. The source text does not specify the number of units affected or report any illnesses or injuries associated with the defect.
The recalled product
- Product
- 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
- Manufacturer
- Ethicon Endo-Surgery Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- ZJLBBR
- ZJLBBT
- ZJLBBV
- ZJMBB5
- ZJMBCG
- ZJMBCH
- ZJMBCJ
- ZJMBCK
- ZJMBCL
- ZJMBJC
- ZJMBJD
- ZJMBJF
- ZJPBD1
- ZJPBD2
- ZJPBFT
- ZJPBFV
- ZKBBCC
- ZKBBCD
- ZKBBCF
- ZKBBCG
Distribution
Part of a larger recall action
This product is one of 3 recalled by Ethicon Endo-Surgery Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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