Integra Flowable Wound Matrix Recalled for Stability Criteria Failures
Integra LifeSciences is recalling 287 packages of Flowable Wound Matrix because the product failed stability acceptance criteria for visual appearance and force vs. displacement.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a failure to meet stability acceptance criteria (visual appearance and force vs. displacement), which is a quality control issue without reported harm, fitting the Moderate severity criteria for low-risk or precautionary recalls.
Plain-English summary
Integra LifeSciences Corp. is recalling 287 packages of Flowable Wound Matrix, a single-use, sterile medical device used for wound management. The affected products are identified by Model Numbers FWD301 (US) and FDR301 (Non-US). The recall involves specific lot numbers for the packaged kits and the syringes within them, including kit lots 305000293250, 305000293251, and 305000298616.
The recall was initiated because a lot of the product distributed in late 2013 and early 2014 was verified as not meeting stability acceptance criteria. Specifically, the product failed to meet criteria for visual appearance during dispensing and force vs. displacement, which refers to the force needed for the product to be extruded from the syringe.
The affected units were distributed worldwide, including in the United States and in Greece, France, Italy, Spain, Switzerland, South America, Turkey, and the United Kingdom. The source text does not report any illnesses, injuries, or deaths associated with this recall. Healthcare providers and patients should check their inventory and product packaging for the affected lot numbers and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Wound Care
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 (4)
- 305000293251
- the corresponding respective syringe Lot Numbers are: - 10500028786
- 105000288118
- 105N00288965 (foreign)
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · stability failure
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateVasocaine lidocaine spray recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateZone 1 lidocaine cream recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateZone 2 lidocaine cream recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateCiclopirox shampoo recalled after failing impurity specifications at eighteen months
FDA (Drugs) · 2025-12-24