Class I U.S. Food and Drug Administration

Given Imaging Ltd. Bravo CF capsule delivery device, 5-pack recall: Capsule may fail to attach to the esophagus or detach from the delivery

Recall published last month

Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

The hazard: Laceration or amputation hazard

This recall is about a cutting injury: a blade, edge or part that can reach the user when it should not.

What the notice says: Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

Why it matters: A blade, edge or moving part can cut the user, or a part can break and come apart in the hand. With powered tools, the same defect that causes a cut can cause a much worse injury.

Symptoms and when to call a doctor

Control bleeding with firm, direct pressure using a clean cloth and raise the limb if you can. Go to an emergency department for a wound that will not stop bleeding, that gapes open, that is deep or dirty, that involves a hand, face or joint, or where feeling or movement has changed. If a body part has been severed, call 911, wrap the part in clean damp gauze, seal it in a bag and keep the bag on ice — never directly on ice.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-3090-2026
Published
September 16, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Given Imaging Ltd.
Product type
Medical devices
Units affected
127,416
Distribution
Nationwide
Made in
Israel
Lot / code info
Product Number FGS-0635 UDI-DI (GTIN) 07290101369707 Product Number FGS-0636 UDI-DI (GTIN) 07290101369714 Expiration dates prior to and including October 20, 2027 (lot numbers from 64553F up to and including 68912F)
UPC codes
07290101369707, 07290101369714

Products covered by this recall

Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.

Check your product

The notice names 11 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07290101369707
  • 07290101369714

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • from 64553F up
  • including 68912F

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • including October 20

Model or item number

On the rating label, the box or the instruction sheet.

  • FGS-0635
  • 1-pack
  • FGS-0635 UDI-DI
  • FGS-0636 UDI-DI

Package size

Match the net weight or the piece count on the front of the pack.

  • 5 pack
  • 1 pack

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Laceration

Given Imaging Ltd. — This recall is about a cutting injury: a blade, edge or part that can reach the user when it should not.

  1. Stop using the product and unplug it, or take the battery out if it is cordless.
  2. Follow the remedy on this page and keep the receipt or order confirmation if you have one.
  3. Do not try to grind off, tape over or otherwise work around a sharp part — you cannot restore the guard the design is missing.
  4. Keep it away from children, and from anyone else in the household who might pick it up without knowing.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.

Company contact: Given Imaging Ltd. — New Industrial Park, Yokne'Am Ilit

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Given Imaging Ltd. medical devices recalled?

Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient. Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07290101369707, 07290101369714; lot code from 64553F up, including 68912F; best-by date including October 20; model number FGS-0635, 1-pack, FGS-0635 UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and unplug it, or take the battery out if it is cordless.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls