Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180…
Due to unsealed portions of pouches.
Read the official notice →- Date
- 2026-06-24
- Country
- United States
- Brand
- Merit Medical Systems
- Product
- Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution in the states and territory AL, 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Merit Medical Systems recalls
- 2026-10-07
US
Merit Medical Systems, Inc. recalls Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe…
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of CA, GA and the…Official notice →- 2026-05-06
US
Merit Medical Systems, Inc. recalls Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
FDA · DeviceMerit Medical Systems, Inc.US Nationwide distribution in the state of CO.Official notice →- 2026-04-01
US
Merit Medical Systems, Inc. recalls CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K,…
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss…
FDA · DeviceMerit Medical Systems, Inc.Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL,…Official notice →- 2026-01-28
US
Merit Medical Systems, Inc. recalls Allwell Inflation Device, for angiographic use REF: IS-30-A
Inflation device handle may detach from the syringe during procedure.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ,…Official notice →- 2025-11-26
US
Merit Medical Systems, Inc. recalls PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A,…
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
FDA · DeviceMerit Medical Systems, Inc.US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS,…Official notice →- 2025-09-17
US
Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329…
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY,…Official notice →
Other drugs & medical recalls in the United States
- 2026-07-01
US
US
- 2026-06-24
US
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product…
Due to 11 volt Backup Battery failures.
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →US
Inspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The…
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or…
FDA · DeviceInspire Medical Systems Inc.Worldwide distribution - US Nationwide and the country of Hong Kong.Official notice →US
BD SWITZERLAND SARL recalls BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication…
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive…
FDA · DeviceBD SWITZERLAND SARLU.S.: AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI,…Official notice →US
Beta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the…
FDA · DeviceBeta Bionics, Inc.US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA,…Official notice →