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Displaying 1 - 15 of 150 items.
Monnal T60
During a ventilation sequence, the user started the "100% O2" function. This function lasts for two minutes but can be interrupted by pressing the 100% O2 key. Note: after the 100% O2 function has been used, the FiO2 setpoint originally entered is…
RecallHealth product recall | 2023-03-24
Diclofenac Sodium Micronized: Out of specification in the affected lot.
The Loss on Drying is out of specification in the affected lot.
RecallHealth product recall | 2023-03-21
Express Mini 500 and Pneumostat Chest Drain Valve
The instructions for use (IFU) for the Pneumostat Chest Drain Valve and for the Express Mini 500 do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning…
RecallHealth product recall | 2023-03-15
Tempus Pro
During internal testing, regulatory compliance issues regarding fluid ingress and basic safety issues have been identified with the Tempus Pro monitor, ac mains power supply, and the vehicle adaptor. the tempus pro device's labeling indicates that the…
RecallHealth product recall | 2023-03-10
CAYSTON: Vials may be cracked in affected lots
Vials may be cracked in affected lots.
RecallHealth product recall | 2023-03-03
Heparin Sodium Injection: Out of Specification
Potential low Anti-Factor Ila potency out of specification.
RecallHealth product recall | 2023-03-01
Probiotic Blister: Out of Specification
Bacteria content is below specification in the affected lot.
RecallHealth product recall | 2023-03-01
ProbioMax 50 Billion: Out of Specification
Bacteria content is below specification in the affected lot.
RecallHealth product recall | 2023-03-01
Vital Vision Plus Omega 3: Incorrect label for pediatric subpopulation
Affected lots are incorrectly labelled for use in the pediatric subpopulation.
RecallHealth product recall | 2023-02-24
Luminos, Uroskop and Axiom Systems
Results of post market surveillance revealed that under certain circumstances the room configuration parameters of the system are set to default values. If these values are larger than the actual room dimensions, a collision with the ceiling or wall…
RecallHealth product recall | 2023-02-24
BD Insulin Syringes With The BD Micro-Fine IV Needle
The affected products were manufactured using unvalidated materials that can result in unsealed packaging for the individual syringes.
Recall start date: February 3, 2023
RecallHealth product recall | 2023-02-17
Ballard Oral Care Swab
This medical device recall (correction) has been initiated due to certain lots labeled with incorrect expiration dates. The labeled expiration dates of impacted products were printed with a 10-year expiration date however, the products have an…
RecallHealth product recall | 2023-02-17
Kirkland Signature Extra Strength Acetaminophen Tablets 500 mg: Out of Specification
The dissolution is out of specification in the affected lot.
RecallHealth product recall | 2023-02-17
Freestyle Libre Sensor Kits
It was identified that two (2) Freestyle Libre sensor reel lots manufactured by Abbott Diabetes Care (ADC) failed retain testing. As a result of the investigation and testing of retains, the sensors were found to give clinically significant readings…
RecallHealth product recall | 2023-02-16
Cholester-Aid: Reported adverse reactions
Affected lot being voluntarily recalled due to reported adverse reactions possibly to niacin (reddening skin flush, heat sensation).
RecallHealth product recall | 2023-02-14