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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80079

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 22, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Apollo Endosurgery Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2743-2018
Recall number
Z-2743-2018
Initiated
November 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Apollo Endosurgery Inc
Quantity
54

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Component of the Lap-Band system was missing from the package

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Component of the Lap-Band system was missing from the package

Code information

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

Distribution pattern

Worldwide Distribution - FL, IL, LA, MI, MO, NC, NY, TN, TX, VA and WV and the countries of France, Italy, Spain, and United Kingdom