Bolton Medical Inc. recalls The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg…
Potential for the incorrect size stent-graft than the printed carton label.
Read the official notice →- Date
- 2023-06-14
- Country
- United States
- Brand
- Bolton Medical
- Product
- The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of FL, NY,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Bolton Medical recalls
- 2026-06-03
USBolton Medical Inc. recalls RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U…
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
FDA · DeviceBolton Medical Inc.Worldwide - distribution in the US Territory of Puerto Rico and the countries…Official notice →- 2024-04-03
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Bolton Medical Inc. recalls RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part…
The stent-graft inside the delivery system was the incorrect size.
FDA · DeviceBolton Medical Inc.Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The…Official notice → - 2023-01-25
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Bolton Medical Inc. recalls RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
The product may be shorter than packaging indicates
FDA · DeviceBolton Medical Inc.Worldwide distribution - US Nationwide and the countries of UK, France,…Official notice →
Other drugs & medical recalls in the United States
- 2023-06-14
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Mechatronics USA recalls RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the…
QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range.
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DeRoyal Industries Inc recalls Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05,…
The custom procedure packs contain light handle covers that have been recalled by another firm.
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Cardinal Health 200, LLC recalls Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Inadvertently released for distibution without sterility assurance.
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Avanos Medical, Inc. recalls AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Some of the ambIT kits were potentially distributed without an air in-line filter.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide distribution in the states of Texas and…Official notice → - US
Qiagen Sciences LLC recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Faulty cartridges in the lot could result in false test results.
FDA · DeviceQiagen Sciences LLCUS Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.Official notice → - US
Becton Dickinson & Co. recalls BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous…
IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the…
FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW.Official notice →