Applied Medical Recalls Wilson Implantation System Due to Sterilization Breach
Applied Medical Technology Inc is recalling 1,100 units of the Wilson Implantation System after a complaint revealed an open pouch that breached sterilization validation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a breach of sterilization validation, which poses a risk of infection or harm during surgery, but the source text does not report any specific illnesses, injuries, or fatalities, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Applied Medical Technology Inc is recalling 1,100 units of the Wilson Implantation System, Part Number TLC5042-M. The device is indicated to aid in tissue retraction during surgical procedures. The recall was initiated after the firm received a complaint regarding an open pouch, which breaches the sterilization validation for the product.
The affected products were shipped to 28 U.S. states, including Alabama, Arizona, California, and Texas, as well as to several international countries including Austria, Germany, and the United Kingdom. The source text does not specify the exact dates of distribution or the specific facilities receiving the units.
Consumers and healthcare providers should stop using the affected Wilson Implantation System units immediately. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violation could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
- Manufacturer
- Applied Medical Technology Inc
- Affected units
- 1,100
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-M
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 Penile Implantation System Retractor Frame
FDA (Devices) · 2016-05-11
- HighNavilyst Medical Recalls Port Kits Due to Sterilization Barrier Breach
FDA (Devices) · 2014-02-05
Similar recalls
- HighAbeon Wilson Penile Implantation System Retractor Frame Recalled for Sterility Compromise
FDA (Devices) · 2016-01-27
- HighBoston Scientific Recalls Colpassist Vaginal Positioning Device Due to Sterility Risk
FDA (Devices) · 2021-05-05
- ModerateNobel Biocare Recalls Implant Retrieval Kits Due to Sterility Concerns
FDA (Devices) · 2020-02-26
- HighMicroAire Steinmann Pins Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2013-09-11
- ModerateAmerican Medical Systems Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- HighBiomet Reverse Shoulder System Recalled for Potential Sterile Seal Breach
FDA (Devices) · 2020-12-23