Avid Medical Recalls TruCustom Ortho Tray Kits Due to Foreign Material
Avid Medical is recalling 597 TruCustom Ortho Tray 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 involves a medical device with a foreign material defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Avid Medical, Inc. is recalling 597 units of AVID TruCustom ORTHO TRAY convenience kits (Item Codes LGHM004-07 and LGHM004-08). 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. Specific lot numbers and expiration dates include 1194408 (10/1/2018), 1204116 (10/1/2018), 1216669 (12/1/2018), and 1216670 (11/1/2018).
Consumers and healthcare providers should stop using these kits and contact Avid Medical for further instructions.
The recalled product
- Product
- AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 597
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 (8)
- Lot
- Expiration Date: 1194408
- 10/1/2018
- 1204116
- 1216669
- 12/1/2018
- 1216670
- 11/1/2018
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 Robotic Prostatectomy Packs for 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 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 MOHS Procedure Trays with Unlabeled Latex Dressing
FDA (Devices) · 2016-08-24
- HighAvid Medical Recalls Unlabeled Latex-Containing Telfa Dressing Kits
FDA (Devices) · 2016-08-24
- HighHalyard Pacemaker Tray Surgical Kits Recalled for Loose Metal Flakes
FDA (Devices) · 2024-11-20
- ModerateB. Braun Recalls Pain Management Trays with Foreign Matter
FDA (Devices) · 2018-02-21
- ModerateB. Braun Recalls Epidural Anesthesia Kits Due to Foreign Matter
FDA (Devices) · 2018-02-21
- HighHalyard Angio Tray surgical kits recalled for loose metal flakes
FDA (Devices) · 2024-11-20