Browse Device Recalls
28 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 28 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 28 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 2, 2024 | Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA... | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. | Class II | Coloplast Manufacturing US, LLC |
| Dec 2, 2024 | X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB611... | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. | Class II | Coloplast Manufacturing US, LLC |
| Mar 11, 2024 | Ureteral dilator, REF RBD014 | A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facil... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Pr... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prost... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile P... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prost... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Pr... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile P... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prost... | XXX | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile ... | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Mar 1, 2023 | Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... | Class II | Coloplast Manufacturing US, LLC |
| Nov 9, 2021 | Torosa Saline-Filled Testicular Prosthesis (Size Small) | Product is mislabeled for size. | Class II | Coloplast Manufacturing US, LLC |
| Oct 23, 2020 | Titan Pump - Product Usage: indicated for male patients suffering from erecti... | Potential increased occurrence of pump fracture over the lifetime of the device. | Class II | Coloplast Manufacturing US, LLC |
| Mar 22, 2016 | Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 30... | Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 ca... | Class II | Coloplast Manufacturing US, LLC |
| Apr 9, 2015 | Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/5... | Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box an... | Class II | Coloplast Manufacturing US, LLC |
| Sep 29, 2014 | Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5... | Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam whe... | Class II | Coloplast Manufacturing US, LLC |
| Sep 8, 2014 | Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Cou... | Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound d... | Class III | Coloplast Manufacturing US, LLC |
| May 13, 2013 | Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of... | Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2... | Class II | Coloplast Manufacturing US, LLC |
| Apr 12, 2013 | Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Colopla... | Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorre... | Class II | Coloplast Manufacturing US, LLC |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.