Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure
Ethicon Endo-Surgery Inc is recalling 2,475 Adjustable Gastric Bands because aging studies showed they failed to meet Force to Lock test requirements.
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 involves a high-risk medical device (gastric band) where a functional defect (failure 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 2,475 units of the Adjustable Gastric Band, Product Code 2200-X. The device is intended for use in the surgical treatment of morbid obesity and was distributed worldwide, including nationwide in the United States and in numerous other countries.
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 units are packaged alone in transparent PETG inner and outer blisters with Tyvek lids.
The following lot numbers are affected: ZLGBC5, ZLNBCW, ZLNBJC, ZLPBB9, ZMBBBB, ZMCBBC, ZMGBCJ, ZMHBBT, ZMHBCV, ZMLBD0, ZMMBCD, ZMPBBC, ZNCBC6, ZNGBB3, and ZNGBBF. Consumers and healthcare providers should contact Ethicon Endo-Surgery Inc for further instructions regarding the recall.
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 (14)
- ZLNBCW
- ZLNBJC
- ZLPBB9
- ZMBBBB
- ZMCBBC
- ZMGBCJ
- ZMHBBT
- ZMHBCV
- ZMLBD0
- ZMMBCD
- ZMPBBC
- ZNCBC6
- ZNGBB3
- and ZNGBBF.
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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