TriMed Nitinol Staples Recalled Due to Missing Sterilization Audit Records
TriMed Inc. is recalling 323 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.
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 involves a risk of patient infection from potentially non-sterile medical devices, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TriMed Inc. is recalling 323 units of Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, including models ES-18x14, ES-20x20, and ES-25x22. The recall was initiated after a retrospective review of sterilization records revealed that evidence of quarterly dose audits and verification, required for regulatory compliance, could not be located.
Although sterilization records indicate that all lots of staples were irradiated to at least the defined dose, the missing audit documentation creates a risk that the devices may not have been properly sterilized. This issue could potentially result in patient infection if the staples were used in a non-sterile state.
The affected products were distributed in the United States to Illinois, Utah, Pennsylvania, New Jersey, Washington, Texas, Nevada, California, North Carolina, Mississippi, Kansas, Missouri, Minnesota, and Florida, as well as in Australia and Sweden. Healthcare providers and facilities should stop using the affected lots and contact TriMed Inc. for further instructions.
The recalled product
- Product
- Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
- Manufacturer
- TriMed Inc.
- Affected units
- 323
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 (20)
- Lot #: a) R900
- 009J
- 050511
- 00AG
- 0095
- 183601
- 10505-11
- 193601
- b) R903
- 26404
- 264-04
- 03NK
- 050512
- 10505-12
- 24604
- 11811
- 181102
- 181103
- 188803
- c) 26405
Distribution
Part of a larger recall action
This product is one of 4 recalled by TriMed 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 · TriMed Inc.
See all →- HighTriMed Threaded IM Nail System Recalled for Driver-Socket Defect
FDA (Devices) · 2024-05-22
- HighTriMed Threaded IM Nails Recalled Due to Out-of-Spec Driver-Socket Defect
FDA (Devices) · 2024-05-22
- HighVolar Bearing Plate wrist fixation systems recalled for bearing dislodgement
FDA (Devices) · 2024-02-07
- HighRipCord Syndesmosis Button suture may break during orthopedic surgery
FDA (Devices) · 2023-02-15
- HighTriMed Recalls Olecranon Hook Plates Due to Unqualified Hole Modification
FDA (Devices) · 2019-11-20
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- SevereCustomed Skin Staple Removal Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereTrimix Injectable Vials Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-03-23
- SeverePallimed Solutions Recalls Trimix Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-08-21
- HighFDA Recalls 222 Units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reloads
FDA (Devices) · 2021-04-21
- ModerateTriMed Peg Guide Extender Recalled Due to Rusting Spring Hazard
FDA (Devices) · 2019-11-20
- SevereEstradiol Pellets Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23