Argon Medical Devices, Inc recalls BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03,…
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to…
Read the official notice →- Date
- 2024-10-02
- Country
- United States
- Brand
- Argon Medical Devices
- Product
- BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03,…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AZ, FL, OH,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Argon Medical Devices recalls
- 2026-08-05
USArgon Medical Devices, Inc recalls L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may…
FDA · DeviceArgon Medical Devices, IncUS: AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC,…Official notice →- 2026-07-22
- US
Argon Medical Devices, Inc recalls General Biospy Tray, REF: GUTS1000
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA · DeviceArgon Medical Devices, IncDistribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.Official notice → - 2025-12-03
- US
Argon Medical Devices, Inc recalls Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the…
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is…
FDA · DeviceArgon Medical Devices, IncU.S. (nationwide) distribution to states of: AL, AR, AZ, CA, CO, CT, DC, FL,…Official notice → - 2024-08-21
- US
Argon Medical Devices, Inc recalls L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.
FDA · DeviceArgon Medical Devices, IncUS distribution to the states of: TX, WA, CA, ILOfficial notice → - 2023-08-02
- US
Argon Medical Devices, Inc recalls Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO,…
There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
FDA · DeviceArgon Medical Devices, IncUS Nationwide distribution in the state of TX.Official notice → - 2022-02-16
- US
Argon Medical Devices, Inc recalls 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
FDA · DeviceArgon Medical Devices, IncUS Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV,…Official notice →
Other drugs & medical recalls in the United States
- 2024-10-02
- US
Microcare Medical recalls Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution,…
Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product…
FDA · DeviceMicrocare MedicalWorldwide - US Nationwide distribution in the states of MN, GA, PA, WA, CO,…Official notice → - US
Bard Peripheral Vascular Inc recalls BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System…
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution in the Puerto Rico and the countries…Official notice → - US
Philips North America Llc recalls Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal…
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Merit Medical Systems, Inc. recalls Custom Procedure Kit, REF: K12T-11077
7F sheath introducers labeled as 7.5F
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA,…Official notice → - US
CooperSurgical, Inc. recalls Stainless Steel Sims Uterine Sound, Part Number 64-601
During the manufacturing process the devices were laser-marked with the incorrect part number.
FDA · DeviceCooperSurgical, Inc.Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain,…Official notice → - US
Roche Diagnostics Operations, Inc. recalls Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination…
Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.