Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone…
Medical device recall Z-2743-2018. Published in FDA’s Enforcement Report on Aug 22, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 22, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 11 states named in where it went
- 54 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Component of the Lap-Band system was missing from the package
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed laparoscopically around the stomach, creating a small pouch or stoma, thereby limiting food consumption. The band can be inflated or deflated with saline, through the access port, depending on patient needs and progress. The Lap-Band access port is a low-profile cylindrical port attached to kink-resistant tubing . The port is implanted subcutaneously or in the rectus muscle and can be penetrated in its silicone septum by a non-coring needle to inject or remove saline into or from the band. The kink-resistant tubing connects the access port to the band.
54, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item Lot # Serial # C-2306 AF00921 S0034428 C-2306 AF00921 S0034429 C-2306 AF00921 S0034430 C-2306 AF00921 S0034431 C-2306 AF00921 S0034433 C-2306 AF00921 S0034435 C-2306 AF00921 S0034437 C-2306 AF00921 S0034439 C-2306 AF00921 S0034441…
Every code shown here, 1,637 characters
Item Lot # Serial # C-2306 AF00921 S0034428 C-2306 AF00921 S0034429 C-2306 AF00921 S0034430 C-2306 AF00921 S0034431 C-2306 AF00921 S0034433 C-2306 AF00921 S0034435 C-2306 AF00921 S0034437 C-2306 AF00921 S0034439 C-2306 AF00921 S0034441 C-2306 AF00921 S0034443 C-2306 AF00921 S0034445 C-2306 AF00921 S0034447 C-2306 AF00921 S0034449 C-2306 AF00921 S0034450 C-2306 AF00921 S0034451 C-2306 AF00921 S0034453 C-2306 AF00921 S0034455 C-2306 AF00921 S0034457 C-2306 AF00921 S0034440 C-2306 AF00921 S0034433 C-2306 AF00921 S0034450 C-2306 AF00921 S0034434 C-2306 AF00921 S0034436 C-2306 AF00921 S0034438 C-2306 AF00921 S0034444 C-2306 AF00921 S0034446 C-2306 AF00921 S0034448 C-2306 AF00921 S0034452 C-2306 AF00921 S0034454 C-2306 AF00921 S0034456 C-2306 AF00921 S0034442 C-2306 AF00921 S0034432 C-20360 AF00929 S0034459 C-20360 AF00929 S0034460 C-20360 AF00929 S0034461 C-20360 AF00929 S0034463 C-20360 AF00929 S0034464 C-20360 AF00929 S0034466 C-20360 AF00929 S0034467 C-20360 AF00929 S0034468 C-20360 AF00929 S0034469 C-20360 AF00929 S0034470 C-20360 AF00929 S0034472 C-20360 AF00929 S0034473 C-20360 AF00929 S0034460 C-20360 AF00929 S0034465 C-20360 AF00929 S0034480 C-20360 AF00929 S0034486 C-20360 AF00929 S0034467 C-20360 AF00929 S0034469 C-20360 AF00929 S0034473 C-20360 AF00929 S0034458 C-20360 AF00929 S0034462 C-20360 AF00929 S0034471 C-20360 AF00929 S0034474 C-20360 AF00929 S0034475 C-20360 AF00929 S0034476 C-20360 AF00929 S0034477 C-20360 AF00929 S0034478 C-20360 AF00929 S0034479 C-20360 AF00929 S0034481 C-20360 AF00929 S0034482 C-20360 AF00929 S0034483 C-20360 AF00929 S0034484 C-20360 AF00929 S0034485 C-20360 AF00929 S0034487
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - FL, IL, LA, MI, MO, NC, NY, TN, TX, VA and WV and the countries of France, Italy, Spain, and United Kingdom
The states and territories these words name
- Florida
- Illinois
- Louisiana
- Michigan
- Missouri
- North Carolina
- New York
- Tennessee
- Texas
- Virginia
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 22, 2017.
- FDA classified it on Aug 10, 2018.
- FDA’s Enforcement Report published it on Aug 22, 2018.
- FDA terminated it on Oct 6, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Apollo Endosurgery Inc, of West Lake Hills, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.