Z-2241-2023Class II

Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460

Name: Z-2241-2023 Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Creator: Davol, Inc.
Published: 2023-04-25
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2023-04-25 / Open, Classified

FDA source

Davol, Inc. began a recall of Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460 on 2023-04-25. FDA classified it as Class II and gives the reason as "Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2241-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-25
Posted: 2023-07-27
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
FDA root cause: Under Investigation by firm
Action: BD issued Urgent Medical Device Product Recall letter on 4/25/23 via FedEx 2-day and email. Letter states reason for recall, health risk and action to take: 1. Please immediately discontinue use of the affected product. Check all inventory locations within your facility and destroy all affected product in accordance with your facility s process. 2. Share this notification with all users of the affected product within your facility network to ensure they are also aware of this product recall. 3. If you purchased the affected product from a distributor, contact your distributor directly for further instructions and credit resolution. 4. Complete the attached Customer Response Form and return it to the BD contact noted on the form whether or not you have any of the affected product so that BD may acknowledge your receipt of this notification per FDA requirements. 5. Indicate on the response form the quantity of affected product identified at your facility and confirm that this product inventory was destroyed. 6. Please contact your BD representative if you require assistance with this process, or you may also contact BD. 1. BD will issue replacements for destroyed product to customers that purchased product directly from BD following receipt of the completed Customer Response Form. 2. BD is implementing actions to prevent recurrence of this product issue. Contact Information: If you require further assistance please contact: BD Contact Contact Information Areas of Support North American Regional Complaint Center Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: [email protected] Recall questions, Product Complaints, Technical Questions
Quantity in commerce: 1188 units US; 5 units OUS
Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.
Product codes and lots: UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: HUGS0481 HUGS0549 HUGS1019 HUGS2031 HUGS2079 HUGT1627 HUGS2025 HUGT1989

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2241-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2241-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-27
Z-2242-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-27
Z-2243-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-27
Z-2244-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-27

Product code FTL

K130968Class IIVentralight St Mesh with Echo Ps Positioning SystemC.R. Bard, Inc. / cleared 2013-05-01

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)