Covidien LLC recalls HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI…
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Read the official notice →- Date
- 2026-03-18
- Country
- United States
- Brand
- Covidien
- Product
- HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Covidien recalls
- 2026-06-10
USCovidien, LP recalls Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
FDA · DeviceCovidien, LPDomestic: Nationwide distribution; International: Austria, Canada, Denmark,…Official notice →- US
Covidien LLC recalls Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Temperature probe devices lack FDA clearance.
FDA · DeviceCovidien LLCUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
Covidien LLC recalls COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in…
Due to customer complaint regarding incorrect display box labeling.
FDA · DeviceCovidien LLCWorldwide - U.S.: Nationwide distribution in the state of TX and the countries…Official notice → - 2025-11-19
- US
Covidien, LP recalls Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - 2025-07-30
- US
Covidien recalls Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941,…
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient…
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of MS, TX, FL,…Official notice → - 2025-06-18
- US
Covidien recalls Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU.…
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation,…
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of MA, CT, KS,…Official notice →
Other drugs & medical recalls in the United States
- 2026-03-18
- US
Medline Industries, LP recalls Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE,…
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
FDA · DeviceMedline Industries, LPWorldwide - US Nationwide distribution in the state of CA and the countries of…Official notice → - US
- US
Lutronic Corporation recalls CLARITY II Laser System; Model No. 1110200210.
Reports of devices sparking/popping and potentially burning patients.
FDA · DeviceLutronic CorporationWorldwide distribution - US Nationwide and the countries of Canada, South…Official notice → - US
International Life Sciences recalls Artelon FlexBand Dynamic Matrix Ref: 31057
Augmentation devices failed bacterial endotoxin testing.
FDA · DeviceInternational Life SciencesWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Beckman Coulter Mishima K.K. recalls CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases…
FDA · DeviceBeckman Coulter Mishima K.K.US Nationwide distribution including in the states of NE, WA, PA, CA, AZ, NC,…Official notice → - US
Boston Scientific Corporation recalls EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This…