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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Coloplast Manufacturing US, LLC: 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.; XXX

Agency Publication Date: April 12, 2023
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Affected Products

Product: Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

UDI/DI 05708932539128, Lot Numbers: 8849582, 8849603, 8904185

Lot Numbers:
Numbers
Product: Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis

UDI/DI 05708932539142, Lot Numbers: 8849563, 8849585, 8904187

Lot Numbers:
Numbers
Product: Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis

UDI/DI 05708932539173, Lot Numbers: 8840677

Lot Numbers:
Numbers
Product: Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis

UDI/DI 05708932539197, Lot Numbers: 8904188, 8806754, 8806755

Lot Numbers:
Numbers
Product: Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis

UDI/DI 05708932539203, Lot Numbers: 8806758, 8806757

Lot Numbers:
Numbers
Product: Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis

UDI/DI 05708932487245, Lot Numbers: 8849577, 8849578

Lot Numbers:
Numbers
Product: Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

UDI/DI 05708932487344, Lot Numbers: 8849599, 8887865, 8939119, 8904178, 8904179

Lot Numbers:
Numbers
Product: Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

UDI/DI 05708932487368, Lot Numbers: 8849601, 8849600, 8849621

Lot Numbers:
Numbers
Product: Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis

UDI/DI 05708932487382, Lot Numbers: 8849602, 8904182, 8840688, 8849622

Lot Numbers:
Numbers
Product: Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis

UDI/DI 05708932072557, Lot Numbers: 8840684

Lot Numbers:
Numbers
Product: Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis

UDI/DI 05708932072595, Lot Numbers: 8887620, 8939124

Lot Numbers:
Numbers
Product: Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis

UDI/DI 05708932072649, Lot Numbers: 8887622, 8965351

Lot Numbers:
Numbers
Product: Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis

UDI/DI 05708932072564, Lot Numbers: 8829594, 8849571, 8806760, 8840685

Lot Numbers:
Numbers
Product: Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis

UDI/DI 05708932533966, Lot Numbers: 8849559, 8849560, 8849623, 8887867, 8849624, 8497256, 8904186

Lot Numbers:
Numbers
Product: Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis

UDI/DI 05708932319621, Lot Numbers: 8904177, 8849617

Lot Numbers:
Numbers
Product: Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis

UDI/DI 05708932072519, Lot Numbers: 8887609

Lot Numbers:
Numbers
Product: Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis

UDI/DI 05708932072526, Lot Numbers: 8849570, 8904168, 8939114

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91800
Status: Active
Manufacturer: Coloplast Manufacturing US, LLC
Manufactured In: United States
Units Affected: 17 products (18 units; 9 units; 0; 7 units; 2 units; 13 units; 2 units; 0; 15 units; 8 units; 1 unit; 20 units; 11 units; 22 units; 25 units; 20 units; 23 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.