Z-1368-2023Class II

Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis

Name: Z-1368-2023 Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
Creator: Coloplast Manufacturing US, LLC
Published: 2023-03-01
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-03-01 / Open, Classified

FDA source

Coloplast Manufacturing US, LLC began a recall of Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis on 2023-03-01. FDA classified it as Class II and gives the reason as "A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1368-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-01
Posted: 2023-04-12
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
Product code: FHW Device, Impotence, Mechanical/Hydraulic
Reason for recall: A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
FDA root cause: Process change control
Action: The firm issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice on 03/01/2023 by UPS next day air. The notice explained the issue and the hazard to health. The notice requests the removal and return of the affected product. Distributors are instructed to notify their customers. For further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email [email protected].
Quantity in commerce: 8 units
Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
Product codes and lots: UDI/DI 05708932539142, Lot Numbers: 8849563, 8849585, 8904187

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1368-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1359-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1360-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1361-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1362-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1363-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1364-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1365-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1366-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1367-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1368-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1369-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1370-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1371-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1372-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1373-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1374-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1375-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12

Product code FHW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)