Recall category
Devices a patient or caregiver can identify as used, worn, implanted, or supplied for their care.
Due to unsealed portions of pouches.
Missing from associated official evidence: action, consumer scope.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled a...
Missing from associated official evidence: action, consumer scope.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or trouble...
Missing from associated official evidence: action, consumer scope.
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect G...
Missing from associated official evidence: action, consumer scope.
Reusable electrodes may not meet expected performance levels.
Missing from associated official evidence: action, consumer scope.
Sterile anchors my lack sterility assurance.
Missing from associated official evidence: action, consumer scope.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Missing from associated official evidence: action.
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive);...
Missing from associated official evidence: action, consumer scope.
A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of th...
Missing from associated official evidence: action, consumer scope.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Missing from associated official evidence: action, consumer scope.
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Missing from associated official evidence: action.
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Missing from associated official evidence: action.
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
Missing from associated official evidence: action, consumer scope.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Missing from associated official evidence: action, consumer scope.
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with...
Missing from associated official evidence: action, consumer scope.
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Missing from associated official evidence: action, consumer scope.
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray...
Missing from associated official evidence: action, consumer scope.
The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
Missing from associated official evidence: action, consumer scope.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Missing from associated official evidence: action, consumer scope.
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where en...
Missing from associated official evidence: action.
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Missing from associated official evidence: action, consumer scope.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality d...
Missing from associated official evidence: action, consumer scope.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
Missing from associated official evidence: action.
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
Missing from associated official evidence: action, consumer scope.
