Avid Medical Recalls TruCustom Laminectomy Kits Due to Foreign Material
Avid Medical is recalling 12 TruCustom Laminectomy Kits because they may contain needles with loose polypropylene foreign material.
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: The recall is classified as FDA Class II, and the hazard involves foreign material in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Avid Medical, Inc. is recalling 12 units of AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02. The recall is due to the presence of BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
The affected kits were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin. The specific lots involved have expiration dates of 6/1/2018 and lot numbers 1197473 and 1213733.
Consumers and healthcare providers should stop using these kits and contact Avid Medical, Inc. for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 12
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)
- Lot
- Expiration Date: 1197473
- 6/1/2018
- 1213733
Distribution
Part of a larger recall action
This product is one of 23 recalled by Avid Medical, 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 23 products in this recall →Related recalls
Same manufacturer · Avid Medical, Inc.
See all →- ModerateAvid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAvid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
FDA (Devices) · 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
Same hazard · foreign material
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- ModerateSo Delicious Dairy Free Salted Caramel Cluster Cashewmilk Recalled for Foreign Material
FDA (Food) · 2026-09-30
- HighWindstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
Similar recalls
- ModerateAvid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- HighAvid Medical Recalls Unlabeled Latex-Containing Telfa Dressing Kits
FDA (Devices) · 2016-08-24