Absorbable Surgical Tacks Recalled for Potential Sterility Compromise
Covidien LP is recalling AbsorbaTack Absorbable Fixation Device 30 due to packaging defects that may compromise product sterility. Fifty-four units were distributed in five states.
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: This is a Class II medical device recall. The hazard is theoretical with no reported illnesses or injuries. However, potential sterility compromise in a surgical device represents a risk-of-harm product. Per the rubric, when no illnesses have been reported and the hazard is theoretical, the score is at most 3.
Plain-English summary
Covidien LP is recalling the AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks (5 mm, Model ABSTACK30). This device is intended for fixation of prosthetic material to soft tissue during minimally invasive and open surgical hernia repair procedures.
The recall is due to a packaging defect in the foil pouch. The side seal may have low seal strength, potentially resulting in a breach of the sterile and moisture barrier that protects the device, and compromising the product's sterility.
Fifty-four units have been distributed nationwide in California, Colorado, Florida, Illinois, and Texas under lot number N3J1860Y. Healthcare facilities that received this product should contact Covidien LP for further instructions.
The recalled product
- Product
- AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
- Manufacturer
- Covidien LP
- Affected units
- 54
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)
- GTIN 20884523006527 Lot number: N3J1860Y
Distribution
Related recalls
Same manufacturer · Covidien LP
See all →- SevereSurgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereRecall of Polysorb Sutures Due to Potential Packaging Integrity Issues
FDA (Devices) · 2020-02-26
- ModerateFDA Recalls Polysorb Braided Absorbable Sutures Due to Packaging Integrity Issues
FDA (Devices) · 2020-02-26
- HighRecall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues
FDA (Devices) · 2020-02-26
- HighPolysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues
FDA (Devices) · 2020-02-26
- ModeratePolysorb Suture Recalled for Potential Packaging Integrity Issues
FDA (Devices) · 2020-02-26
- ModeratePolysorb Suture Recall Due to Packaging Integrity Issues
FDA (Devices) · 2020-02-26