Tornier HRS Max Tuberosity Bodies and Trial
Tornier HRS Max parts were incorrectly labeled and are incompatible with the HRS Max system.
Medical device recalls
Medical device recalls from FDA, newest first.
2 recalls
1 recall
Cardinal Health Monoject Tuberculin Syringes
The outer packaging and blister pack label the product as a 1mL Luer Lock Tuberculin Syringe, but the syringes inside are U-100 Insulin syringes.
1 recall
BD Alaris System with Guardrails Suite MX with Point of Care Unit
The BD Alaris System with Guardrails Suite MX with Point of Care Unit lacks labeling for secure Wi-Fi communication.
2 recalls
Straumann Custom Abutments
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments.
2 products
BiDop 3 Pocket Doppler Blood-Flow Detectors
The BiDop 3 Pocket Doppler has a fetal indication for use that is not cleared.
2 recalls
Artegraft Vascular Graft
The Artegraft Vascular Graft has a labeling mix-up resulting in incorrect lot outer packaging.
Stryker Cub Pediatric Crib
The Cub Pediatric Crib is missing two access door warning labels.
1 recall
Medline Unna-Z Stretch Zinc Paste Bandage
The zinc paste bandage has a labeling error with incomplete ingredients listed.
1 recall
Staar Surgical EVO+ Visian Toric Implantable Collamer Lens (TICL)
The lens is labeled as 12.1 mm but is 12.6 mm, which may cause excessive vault.
1 recall
Encore Medical Reverse Shoulder Prosthesis and EMPOWR 3D Knee Inserts
Knee and humeral socket implants contain incorrect labeling.
3 products
1 recall
Stryker MOLLI 2 System, Introducers, Wand, OncoPen and Tablet
The Molli 2 System needs updated labeling because magnetized surgical tools can dislodge markers during tissue removal.
1 recall
Trividia Health TRUE METRIX Blood Glucose Meter Owner's Booklets and Instructions
The labeling for True Metrix blood glucose meters does not adequately explain the E-5 error code, which could delay treatment.
4 products