Applied Medical Recalls Wilson Penile Implantation System Retractor Frame
Applied Medical Technology Inc is recalling Wilson Penile Implantation System Retractor Frames due to a reported open pouch that breaches sterilization validation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a breach of sterilization validation for a surgical device, which poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Applied Medical Technology Inc is recalling 2,263 units of the Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap. The product is indicated to aid in tissue retraction during surgical procedures and is labeled as single-use, sterile, and prescription-only.
The recall was initiated after the firm received a complaint regarding an open pouch, which breaches the sterilization validation for the device. The affected products are identified by Part Numbers TLC5042 and TLC5042-I.
The recalled products were distributed to hospitals and medical facilities in 28 U.S. states, including Alabama, Arizona, California, and Texas, as well as to several international countries including Austria, Germany, and the United Kingdom. Healthcare providers should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
- Manufacturer
- Applied Medical Technology Inc
- Affected units
- 2,263
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 (1)
- Part #: TLC5042 & TLC5042-I
Distribution
Part of a larger recall action
This product is one of 4 recalled by Applied Medical Technology Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Applied Medical Technology Inc
See all →- HighLong nasal feeding tubes recalled from one lot for possible occlusion
FDA (Devices) · 2025-11-19
- HighNasal feeding tubes recalled from one lot because they may be occluded
FDA (Devices) · 2025-11-19
- HighNasal feeding tubes recalled from a second lot for possible occlusion
FDA (Devices) · 2025-11-19
- HighLarger bore nasal feeding tubes recalled for possible occlusion
FDA (Devices) · 2025-11-19
- HighNinety centimetre nasal feeding tubes recalled for possible occlusion
FDA (Devices) · 2025-11-19
Same hazard · sterilization breach
See all →- HighApplied Medical Recalls TLC Self Retaining Retractor Systems Due to Sterilization Breach
FDA (Devices) · 2016-05-11
- HighApplied Medical Technology Recalls Self-Retaining Retractor Frames Due to Sterilization Breach
FDA (Devices) · 2016-05-11
- HighApplied Medical Recalls Wilson Implantation System Due to Sterilization Breach
FDA (Devices) · 2016-05-11
- HighNavilyst Medical Recalls Port Kits Due to Sterilization Barrier Breach
FDA (Devices) · 2014-02-05