Customed Recalls 51 TLIF Packs Due to Sterility and Contamination Risks
Customed, Inc. is recalling 51 Transforaminal Lumbar Interbody Fusion (TLIF) packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class I medical device with a risk of patient infection due to compromised sterility and manufacturing deficiencies, which aligns with the 'Severe' criteria for significant injury risk or structural defects in medical devices.
Plain-English summary
Customed, Inc. is recalling 51 units of the Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918. The recall involves specific lot numbers: 140312147, 140613795, and 140714523. These medical devices were distributed to Florida, New York, and Puerto Rico.
The recall is being issued due to significant compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. These conditions may result in patient infection.
Healthcare facilities and medical staff who have received these specific lots should stop using the products immediately. The source text does not provide specific instructions for disposal or return, but users should contact the recalling firm or their regulatory authority for further guidance.
The recalled product
- Product
- Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Affected units
- 51
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)
- Lot numbers 140312147 140613795 140714523
Distribution
Part of a larger recall action
This product is one of 179 recalled by Customed, 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 179 products in this recall →Related recalls
Same manufacturer · Customed, Inc
See all →- HighCustomed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Femoral Surgical Pack Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Basic Surgical Pack IV Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
Same hazard · infection
See all →- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
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
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
Similar recalls
- SevereCustomed Recalls TLIF Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Lumbar Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Laminectomy Packs Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10