Spark Biomedical Inc recalls Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Read the official notice →- Date
- 2025-08-20
- Country
- United States
- Brand
- Spark Biomedical Inc
- Product
- Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2025-08-20
USTrinity Biotech USA recalls Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or…
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
FDA · DeviceTrinity Biotech USAWorldwide - US Nationwide distribution in the states of Maryland and Utah. The…Official notice →- US
Thoratec LLC recalls Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product…
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Inconsistent size terminology and color coding used on labeling
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS,…Official notice → - US
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product…
Knee implants contain incorrect labeling (size and/or side incorrect)
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN,…Official notice → - US
Carefree Surgical Specialties recalls Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk…
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
FDA · DeviceCarefree Surgical SpecialtiesUS Nationwide distribution in the states of KY, TX, FL, NC, CO, CA, ID, WV,…Official notice → - US
SPINEART SA recalls Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not…
Cannulated fenestrated polyaxial screws may be incorrectly labeled
FDA · DeviceSPINEART SAUS Nationwide distribution in the states of Florida , Kentucky, California.Official notice →