Bard Peripheral Vascular Inc recalls EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER)…
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to…
Read the official notice →- Date
- 2026-10-07
- Country
- United States
- Brand
- Bard Peripheral Vascular
- Product
- EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Bard Peripheral Vascular recalls
- 2026-02-25
USBard Peripheral Vascular Inc recalls Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Due to damage to outer tray that can potentially compromise the sterile barrier
FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →- 2025-12-17
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Bard Peripheral Vascular Inc recalls Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide distribution in the states of CA, MN, IN, MI, LA.Official notice → - 2025-10-08
- US
Bard Peripheral Vascular Inc recalls Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF…
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use.…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide distribution including in the states of NJ, NY, FL,…Official notice → - 2025-03-12
- US
Bard Peripheral Vascular Inc recalls Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F…
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA,…Official notice → - 2024-11-27
- US
Bard Peripheral Vascular Inc recalls Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF:…
Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle…
FDA · DeviceBard Peripheral Vascular IncWorldwide - US Nationwide including in the states of WA, LA, MN, PA, UT, SC,…Official notice → - 2024-11-20
- US
Bard Peripheral Vascular Inc recalls The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a…
The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead…
FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice →
Other drugs & medical recalls in the United States
- 2026-10-07
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American Nitrile Operations Llc recalls Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604…
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination,…
- US
Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System, Model: uCT 530 with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images…
FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX,…Official notice → - US
Volcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
FDA · DeviceVolcano CorpWorldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA…Official notice → - US
Alere San Diego, Inc. recalls Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/…
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
FDA · DeviceAlere San Diego, Inc.Worldwide - US Nationwide distribution including in the states of IL, PA, FL,…Official notice → - US
HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes:…
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
FDA · DeviceHeartSine Technologies LtdU.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO,…Official notice → - US
Draeger, Inc. recalls VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Potential cracks in the hose, which could lead to leakage or the hose falling off.
FDA · DeviceDraeger, Inc.US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO,…Official notice →