Z-0935-2024Class II

EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in...

Name: Z-0935-2024 EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in...
Creator: Olympus Corporation of the Americas
Published: 2023-11-10
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-11-10 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model... on 2023-11-10. FDA classified it as Class II and gives the reason as "Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0935-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-10
Posted: 2024-01-31
Recalling firm: OLYMPUS Corporation of the Americas
Product: EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Olympus issued Urgent Medical Device Removal Letter on 11/10/23. Firm issued a Correction letter dated December 1, 2023 to the letter of November 10, 2023 including Additional Lot numbers . Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any models and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lots. Any models and lots that are not impacted can remain in inventory and be used. The model/lot number can be found on the box or pouch in Figure 1. 2. Call your Olympus customer service representative at 1-800-848-9024, option 2, with the quantity, model, and lot number of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification: a. Go to https://olympusamerica.com/recall. b. Enter the recall number: 0433 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1.
Quantity in commerce: 1008 units
Distribution: Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
Product codes and lots: UDI-DI: 00821925033184 Lot Numbers: 369624, 377715

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0935-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0933-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0934-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0935-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0936-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0937-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0938-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0939-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0940-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0941-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0942-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0943-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0944-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31

Product code FGE

K180086Class IIGyrus ACMI – EZDilate 3-Stage Balloon Dilatation CatheterGyrus Acmi, Inc. / cleared 2018-03-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)