🍎 Food Class I - Dangerous
Product may be contaminated with Salmonella.
All Recalls
95,114 total recalls in our database
Pineapple, Grapes, and Mango Blend 16oz UPC 68113118039
Country Fresh
🍎 Food Class I - Dangerous
Potential to be contaminated with Listeria monocytogenes
🍎 Food Class I - Dangerous
Products are labeled gluten-free. A batch of flour from the raw material supplier tested positive for gluten so the firm immediately initiated a recall of the affected products.
💊 Drugs Class I - Dangerous
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
🏥 Medical Devices Class I - Dangerous
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
🏥 Medical Devices Class I - Dangerous
Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA
🏥 Medical Devices Class I - Dangerous
Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.
Albumin Gen.2, Catalog 05166861190
Roche Diagnostics Operations
🏥 Medical Devices Class I - Dangerous
Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 11097637
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
🏥 Medical Devices Class I - Dangerous
Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking mechanism
🏥 Medical Devices Class I - Dangerous
The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.
🏥 Medical Devices Class I - Dangerous
The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).
🏥 Medical Devices Class I - Dangerous
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
Tina-quant Complement C4 ver.2, Catalog 05991994190
Roche Diagnostics Operations
🏥 Medical Devices Class I - Dangerous
Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
🏥 Medical Devices Class I - Dangerous
The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.
🏥 Medical Devices Class I - Dangerous
Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.
MediCult Vitrification Cooling Media, Model Number 12284001F
CooperSurgical
🏥 Medical Devices Class I - Dangerous
There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.