Covidien, LLC recalls EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1…
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
Read the official notice →- Date
- 2026-08-26
- Country
- United States
- Brand
- Covidien
- Product
- EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AZ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-08-19
US
Covidien, LP recalls V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON…
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or…
FDA · DeviceCovidien, LPUS Nationwide and the countries of Australia, Austria, Belgium, Bulgaria,…Official notice →- 2026-07-08
US
Covidien LLC recalls Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley…
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
FDA · DeviceCovidien LLCU.S. Nationwide distribution including in the states and territories of AK,…Official notice →- 2026-06-10
US
Covidien, 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 →- 2026-03-18
US
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.
FDA · DeviceCovidien LLCWorldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL,…Official notice →
Other drugs & medical recalls in the United States
- 2026-08-26
US
SDI Limited recalls Dentsply Sirona Capsule Mixer Model No. 5546068
Potential for electrical discharge from unit when unplugged.
FDA · DeviceSDI LimitedUS: AK AL AR AZ CA CO CT DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS…Official notice →US
Intersurgical Inc recalls One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Devices could potentially be occluded or partially occluded.
FDA · DeviceIntersurgical IncUS Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.Official notice →US
Foundation Medicine, Inc. recalls Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Software issue that can cause an increase in spontaneous software closures.
FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution in the states of MA & NC.Official notice →US
Spectral Instruments Inc recalls Lago X
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
US
Bard Access Systems, Inc. recalls BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle…
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove…
FDA · DeviceBard Access Systems, Inc.US: MA, FL, IA, SC, IL, NY, UT, NJ, ID, IN, PA, CA, TX, OH, MO, VA, MD, NC,…Official notice →US
American Regent, Inc. recalls Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC…
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde