
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Page 5 of 24 · 1,199 total recalls

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Lack of Assurance of Sterility

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe...

The devices were distributed without required FDA premarket clearance or approval.

The devices were distributed without required FDA premarket clearance or approval.

The devices were distributed without required FDA premarket clearance or approval.

The devices were distributed without required FDA premarket clearance or approval.

The devices were distributed without required FDA premarket clearance or approval.

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

The devices were distributed without required FDA premarket clearance or approval.

The devices were distributed without required FDA premarket clearance or approval.

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include...

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include...

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include...

catheter may experience resistance when being advanced over the guidewire

Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and...

catheter may experience resistance when being advanced over the guidewire

catheter may experience resistance when being advanced over the guidewire

mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites)


cGMP deviations.

cGMP deviations.


cGMP deviations.



Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October...

Respiratory/sore throat panel test may result in false negative results and control failures.

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number...

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number...

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number...

Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling...

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector...

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector...

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector...

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not...

For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not...

Ten complaints have been received identifying issues at the time of use related to the package seal, including...


cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP)...

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP)...
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