Bacterin Elutia Silicone Surgical Wound Drain Recalled for Cracks
Bacterin International is recalling specific lots of Elutia silicone surgical wound drains because a portion of the drain was found to be cracked.
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, and the defect (cracked silicone) presents a potential risk of harm without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Bacterin International, Inc. is recalling a portion of its Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. The recall was initiated after a portion of a silicone wound drain was found to be cracked. The product is indicated for use in surgical wound drainage.
The affected units are distributed to 13 US consignees located in California, Colorado, Montana, Texas, Utah, and Virginia. This distribution includes 4 customers and 9 other individual contacts in the USA that received marketing samples, plus 4 Bacterin representatives nationwide who received samples. Additionally, 81 boxes were sent to 1 foreign consignee. The specific lot codes affected are 005312, 011012, 012111, 012311, 012511, 013011, 019212, 023611, 023811, 024011, 024211, 025912, 033611, and 042211.
Healthcare providers and consumers should check their inventory for these specific lot codes. If the product is found, it should be removed from use and returned to the distributor or manufacturer for credit or replacement, per standard recall procedures. No specific instructions for end-users are provided in the source text beyond the identification of the defect.
The recalled product
- Product
- Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
- Manufacturer
- Bacterin International, Inc.
- Category
- Medical Device — Surgical Drain
- Hazard
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 (14)
- 005312
- 011012
- 012111
- 012311
- 012511
- 013011
- 019212
- 023611
- 023811
- 024011
- 024211
- 025912
- 033611
- 042211
Distribution
Related recalls
Same manufacturer · Bacterin International, Inc.
See all →- ModerateBacterin OsteoSponge Instrument Kits Recalled for Sterilization Errors
FDA (Devices) · 2015-04-15
- ModerateBacterin Elutia Wound Drains Recalled for Missing Dose Audits
FDA (Devices) · 2014-06-11
- ModerateBacterin OsteoSelect DBM Putty Recalled for Unvalidated Testing Procedure
FDA (Devices) · 2013-04-24
- ModerateBacterin Recalls Expired Osteoselect Demineralized Bone Matrix Putty
FDA (Devices) · 2013-02-20
Same hazard · structural defect
See all →- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- HighLight Boy Recalls GBX12SK Light Towers Due to Frame Bending Risk
NHTSA · 2026-09-01
- SevereKmaier Infant Walkers Recalled for Serious Fall Hazard
CPSC · 2026-08-27
- Highrestor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect
FDA (Devices) · 2026-08-26
- SevereFord Recalls 2026 Maverick, F-150, and Bronco Sport for Joint Issues
NHTSA · 2026-08-25