Smaller pericardial patches recalled over a tensile strength specification failure
Glycar SA is recalling 18 SJM Pericardial Patches, 5 x 10 cm, because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
The SJM Pericardial Patch with EnCap Technology, 5 x 10 cm, model REF C0510, from Glycar SA, is being recalled. The product is an intracardiac patch and pledget material.
The impacted lot may not meet the required tensile strength specification.
The recall covers 18 units carrying UDI/DI 05414734007269, from lot T2506245, expiring 25 May 2028. The product was distributed in the United States.
The FDA has classified this as a Class I recall, its most serious category, used where there is a reasonable probability of serious injury or death. A cardiac patch that falls short of its tensile strength specification is load-bearing once implanted.
Facilities should quarantine the affected lot immediately and follow the firm's instructions.
The recalled product
- Product
- SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
- Manufacturer
- Glycar SA Pty., Ltd.
- Category
- Medical Device — Cardiac implant
- Affected units
- 18
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 (3)
- UDI/DI 05414734007269
- Lot Number T2506245
- exp. 2028.05.25
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Glycar SA Pty., Ltd. 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 2 products in this recall →Related recalls
Same manufacturer · Glycar SA Pty., Ltd.
See all →- CriticalPericardial patches recalled because a lot may not meet tensile strength
FDA (Devices) · 2025-12-03
Other medical device recalls
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects
FDA (Devices) · 2026-10-28
- ModerateMedline Medical Convenience Kits Recalled for Adhesive Removal Issues
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28
- ModerateMedtronic NDI Passive Spheres Recalled for Reflective Material Variation
FDA (Devices) · 2026-10-28
- ModerateThink Surgical Square Driver Recalled for Design Specification Failures
FDA (Devices) · 2026-10-28
Similar recalls
- HighMIC Safety 20 Fr push OTW PEG kits contain recalled lidocaine
FDA (Devices) · 2026-06-17
- HighMIC Safety 20 Fr PEG kits contain recalled lidocaine injection
FDA (Devices) · 2026-06-17
- HighMIC Safety 24 Fr push OTW PEG kits contain recalled lidocaine
FDA (Devices) · 2026-06-17
- ModerateEthicon 5mm Endopath Xcel Trocar Recalled for Insufficient Lubrication
FDA (Devices) · 2018-05-23
- HighMIC Safety 14 Fr PEG kits contain recalled lidocaine injection
FDA (Devices) · 2026-06-17
- ModerateTHERACARE Lidocaine Pain Relief Patches Recalled for Manufacturing Deviations
FDA (Drugs) · 2024-12-04