Customed Neuro Pack Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 132 Neuro Packs because compromised sterility and manufacturing deficiencies may result in 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 is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. The source explicitly states that the compromised sterility may result in patient infection, representing a significant health risk.
Plain-English summary
Customed, Inc. is recalling 132 units of the Neuro Pack (Catalog number 900-1146). This product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units were distributed to Florida, New York, and Puerto Rico.
The recall is being conducted because the products have compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
The affected lot numbers are 140211777, 140513068, 140513475, 140714157, and 140814629. Medical facilities and consumers should stop using these products immediately and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- Neuro Pack, Catalog number 900-1146. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 132
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 140211777 140513068 140513475 140714157 140814629
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 · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighCustomed Neurosurgery Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed NEURO PACK Surgical Kits Recalled for Sterilization Defects
FDA (Devices) · 2015-09-09
- HighCustomed Neuro Pack 3/CS Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- CriticalCustomed Recalls Neuro Spine Packs Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10
- HighCustomed Neuro-Spine Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Neuro Spine Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09