Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure
Ethicon Endo-Surgery Inc is recalling 1,248 units of Adjustable Gastric Bands because they failed to meet Force to Lock requirements during aging studies.
What this means for you
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 involves a high-risk medical device where a functional failure (Force to Lock) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 1,248 units of Adjustable Gastric Bands, product code BD2XV. The devices are intended for use in the surgical treatment of morbid obesity and are packaged in transparent PETG blisters with Tyvek lids.
The recall was initiated because the firm determined during aging studies that the gastric belts were unable to pass the test requirements established for Force to Lock. The affected units are distributed worldwide, including nationwide in the United States and in numerous other countries.
Consumers and healthcare providers should stop using the affected products and contact Ethicon Endo-Surgery Inc for further instructions.
The recalled product
- Product
- 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
- 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)
- ZJMBN9
- ZJNBBV
- ZKDBM6
- ZKDBM7
- ZKFBDC
- ZKGBDY
- ZKHBBJ
- ZKHBCR
- ZKHBFG
- ZKNBCK
- ZKNBHC
- ZLBBFK
- ZLDBB8
- ZLFBBC
- ZLFBGG
- ZLGBFV
- ZLGBG5
- ZLJBCL
- ZLMBBD
- ZLMBYF
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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