AVID TruCustomRecalls & reported problems across all models
Avid Medical, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one AVID TruCustom model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 4
We found 8 models of AVID TruCustom by Avid Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between May 21, 2021 and Oct 15, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Disconnection” (3 reports).
4 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
AVID TruCustom recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 31, 2025Open, Classified
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Z-1743-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Apr 9, 2021Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Z-1787-2021 · Root cause: Environmental control · Recall details · FDA record ↗
- Apr 9, 2021Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Z-1785-2021 · Root cause: Environmental control · Recall details · FDA record ↗
- Apr 9, 2021Terminated
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Z-1784-2021 · Root cause: Environmental control · names 2 of these models · Recall details · FDA record ↗
Most reported AVID TruCustom problems
Device problems
- Disconnection3
- Component Misassembled1
- Failure to Seal1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
AVID TruCustom models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AVID TruCustom RPGH9472-01_0002Cardiovascular procedure kit1 recall0 reports
- AVID TruCustom MMTN020_0006General surgery tray1 recall0 reports
- AVID TruCustom VMED004-03_0003General surgery tray1 recall0 reports
- AVID TruCustom LAKC001-04_0006General surgery tray1 recall0 reports
- AVID TruCustom LAKC001-04_0010General surgery tray1 recall0 reports
- AVID TruCustom VARV043-05_0004General surgery tray3 reports
- AVID TruCustom LLOF1000-17_0002General surgery tray1 report
- AVID TruCustom WHEE005-14_0007General surgery tray1 report
Recent AVID TruCustom adverse event reports
The 5 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Failure to Seal; Failure to Seal
DURING AN ORGAN RECOVERY PROCEDURE, IT WAS DISCOVERED THAT THE PLASTIC BAG CONTAINED WITHIN THE AVID ORGAN RECOVERY PACK WAS NOT PROPERLY SEALED. SPECIFICALLY, THE BOTTOM OF THE BAG LACKED A PROPER SEAL. A RECOVERED LIVER FELL THROUGH THE BAG AND LANDED ON FLOOR. THERE WAS NO ADVERSE IMPACT TO THE DONOR OR ORGAN. THE ORGAN WAS USED BY THE INTENDED RECIPIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23291039 ↗MalfunctionJun 22, 2021Disconnection; Disconnection
COMPLAINT # (B)(4) CAUTERY PIECE BROKE OFF DURING SURGICAL PROCEDURE. THIS IS THE 3RD INCIDENT THAT OCCURRED WITH THE BOVIE. THE BROKEN CAUTERY DID NOT FALL INTO THE SURGICAL SITE. IT DID NOT INCREASE SURGERY TIME. THE NURSING TEAM HAD TO REPLACE THE BOVIE. AVID MEDICAL RECEIVED A COMPLAINT ON 06/08/2021, STATING THAT WHILE USING THE BOVIE SUCTION, THE SUCTION PIECE BROKE OFF DURING THE PROCEDURE. THE CUSTOMER STATED THAT THE BOVIE FUNCTIONED WELL DURING MOST OF THE CASE, BUT FAILED AFTER SEVERAL HOURS. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12040642 ↗MalfunctionJun 10, 2021Disconnection; Disconnection
AVID MEDICAL REPORTED COMPLAINT # (B)(4) THAT A CAUTERY PIECE BROKE OFF AND FELL ONTO THE SURGERY WOUND. TWO EVENTS/BOTH HAD THE SAME MANUFACTURING LOT NUMBER/ SAME AVID KIT LOT NUMBER. WHILE USING THE CAUTERY IN THE STANDARD MANNER, THE CLEAR SUCTION PIECE FELL OFF IN THE FIELD AND APPEARS TO HAVE CRACKED. PER DR. (B)(6) STATED, THE BROKEN PIECE OF EACH BOVIE PEN FELL INTO THE SURGICAL WOUND (ONE CASE WAS A BREAST REDUCTION AND THE OTHER CASE WAS A BREAST RECONSTRUCTION CASE. NEITHER THE PATIENT NOR PERSONNEL WERE HARMED. NO PATIENT INJURY WAS REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11980169 ↗MalfunctionJun 10, 2021Disconnection; Disconnection
AVID MEDICAL REPORTED COMPLAINT # (B)(4) THAT A CAUTERY PIECE BROKE OFF AND FELL ONTO THE SURGERY WOUND. TWO EVENTS/BOTH HAD THE SAME MANUFACTURING LOT NUMBER/ SAME AVID KIT LOT NUMBER. WHILE USING THE CAUTERY IN THE STANDARD MANNER, THE CLEAR SUCTION PIECE FELL OFF IN THE FIELD AND APPEARS TO HAVE CRACKED. PER (B)(6) STATED, THE BROKEN PIECE OF EACH BOVIE PEN FELL INTO THE SURGICAL WOUND (ONE CASE WAS A BREAST REDUCTION AND THE OTHER CASE WAS A BREAST RECONSTRUCTION CASE. NEITHER THE PATIENT NOR PERSONNEL WERE HARMED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11980147 ↗MalfunctionMay 21, 2021Component Misassembled; Component Misassembled
COMPLAINT #: (B)(4) RINGS FROM LAP SPONGES BROKE INTO PIECES AND FELL INTO THE PATIENT ABDOMINAL CAVITY. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 21 STATING THAT RINGS FROM LAP SPONGES BROKE INTO PIECES AND FELL INTO THE PATIENTS ABDOMINAL CAVITY AND HAD TO BE RETRIEVED. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER ALLCARE INC CONCERNING THE ISSUE OF THE RINGS BREAKING APART FOR ITEM NO. AL1818R-800, MANUFACTURER LOT# 21SK02. NO PATIENT INJURY WAS REPORTED. THE BROKEN RING PIECES WERE RETRIEVED SUCCESSFULLY FROM THE PATIENT¿¿S ABDOMINAL CAVITY FOLLOWING THE INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 11863029 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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