Inflatable Penile Prosthesis Titan Recalled Coloplast Manufacturing Class II
Coloplast Manufacturing recalls 20 units of Titan 0-Deg Scrotal inflatable penile prosthesis (Lot Numbers 8849601, 8849600, 8849621) with worldwide distribution. The specific reason for the recall is not specified in FDA records.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II recall with no reported hospitalizations, injuries, or illnesses. This is a voluntary precautionary recall initiated by the manufacturer, fitting the Moderate severity category for device recalls without documented adverse events.
Plain-English summary
Coloplast Manufacturing US, LLC initiated a voluntary Class II recall of the Titan 0-Deg Scrotal 20 Cm inflatable penile prosthesis (Catalog Number ES89202400) affecting 20 units.
The affected lot numbers are 8849601, 8849600, and 8849621. The device has been distributed worldwide, including throughout the United States and to Belgium, France, Germany, Italy, Portugal, Spain, Turkey, and the United Kingdom.
The specific hazard or reason for the recall is not detailed in available FDA records. This is a Class II recall, indicating a serious potential hazard, but no reported injuries or illnesses associated with the product have been documented.
Patients implanted with this device should consult their healthcare provider or contact Coloplast directly for guidance on potential risks and next steps. The recall status is ongoing.
The recalled product
- Product
- Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- device-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI 05708932487368
- Lot Numbers: 8849601
- 8849600
- 8849621
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03