Prismatik Dentalcraft, Inc. recalls Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep…
Due to device not having FDA Clearance
Read the official notice →- Date
- 2026-07-29
- Country
- United States
- Brand
- Prismatik Dentalcraft
- Product
- Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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Other drugs & medical recalls in the United States
- 2026-07-29
- US
AVID Medical, Inc. recalls Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
FDA · DeviceAVID Medical, Inc.U.S. Nationwide distribution in the state of California.Official notice → - US
Boston Scientific Corporation recalls Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL,…Official notice → - US
Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Due to manufacturing issues, reperfusion catheters may fractures
FDA · DevicePenumbra, Inc.Worldwide - US Nationwide distribution including in the states and territories…Official notice → - US
Medtronic Neurosurgery recalls Ventriculostomy Kit, REF: 46154
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with…
FDA · DeviceMedtronic NeurosurgeryWorldwide - US Nationwide distribution in the states of UT, AL, CA, NC, GA,…Official notice → - US
PIE Medical Imaging B.V. recalls 3mensio Workstation (Vascular Fenestrated) software
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur:…
FDA · DevicePIE Medical Imaging B.V.Worldwide - US Nationwide distribution in the states of CA, NY, MN, MI, TX and…Official notice → - US
Medline Industries, LP recalls MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU…
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.