Skip to main content

Biologic recalls

Recalls of blood, tissue, vaccines and related products regulated by FDA’s biologics center, newest first. 222 recalls Each recall is dated by the day its recall page names (how recalls are dated).Browse by hazard
FiltersSort Newest
Agency
Risk level
Status
Date
Sold in

4 recalls that day

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99172

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99171

3 recalls that day

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

The platelets did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99161

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99160

7 recalls that day

The Blood Center Platelets, Pathogen Reduced

Platelets, Pathogen Reduced did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

LifeSouth Community Blood Centers Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Labeling error

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99158

LifeSouth Community Blood Centers Platelets, Pathogen Reduced

Platelets, Pathogen Reduced did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99156

Carter BloodCare Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99150

4 recalls that day

The Blood Connection Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99149

Vitalant Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were collected with a potential for air contamination.

Moderate risk, FDA, Ended, Hospital use, Contamination

Vitalant Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated had a platelet count higher than acceptable.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

3 recalls that day

Medic Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were not tested for hemoglobin and residual white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99152

OneBlood Apheresis Red Blood Cells

Apheresis Red Blood Cells, Irradiated were labeled as leukocytes reduced but were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

West TN Regional Blood Center Platelets, Pathogen Reduced

Platelets, Pathogen Reduced were distributed without pH testing.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

3 recalls that day

OneBlood Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99092

OneBlood Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Labeling error, FDA event number 99091

Mississippi Blood Services Apheresis and Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were distributed.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

3 recalls that day

Mississippi Blood Services Apheresis Platelets and Red Blood Cells

Apheresis red blood cells and platelets labeled as leukocytes reduced were not tested to verify the residual white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

Medic Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99086

ARUP Laboratories Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed without pH testing.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

4 recalls that day

New York Blood Center Fresh Frozen Plasma and Red Blood Cells

The products were collected from donors who previously tested reactive for the antibody to Hepatitis B core antigen on more than one occasion.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Kentucky Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were exposed to unacceptable shipping temperatures.

Low risk, FDA, Ended, Hospital use, Processing problem

Vitalant Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

Abbott Determine HIV 1/2 Ag/Ab Combo

Determine HIV 1/2 Ag/Ab Combo 25T kits may give false positive results due to a subcomponent.

Moderate risk, FDA, Device defect

3 recalls that day

Medic Apheresis Platelets, Leukocytes Reduced, Irradiated

The platelets did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor not tested for Chagas.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99010

3 recalls that day

Blood Bank of Hawaii Apheresis Red Blood Cells, Pooled Cryoprecipitated AHF and Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, collected from a donor who had a hepatitis exposure prior to donation, were distributed.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

ImpactLife Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced tested non-reactive for anti-HCV but were collected from a donor who previously tested repeatedly reactive.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99004

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a donor screening deviation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99003

2 recalls that day

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had no hematocrit check performed during screening.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98960

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98956

2 recalls that day

Department of Air Force Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had a platelet count higher than was acceptable.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

ImpactLife Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who answered "no" to reading educational materials.

Low risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98937

2 recalls that day

We Are Blood Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were collected from a donor who had taken aspirin within 72 hours of donation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Community Blood Center of the Ozarks Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

4 recalls that day

Blood Bank of Hawaii Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98904

Coastal Bend Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Suncoast Communities Blood Bank Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98882

Suncoast Communities Blood Bank Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor in a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98878

1 recall that day

Blood Bank of Hawaii Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor with travel history to a malarial endemic area but not assessed for residency.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98873

2 recalls that day

LifeServe Blood Center Red Blood Cells, Leukocytes Reduced, Irradiated

Red Blood Cells, Leukocytes Reduced, Irradiated were collected from a donor who had traveled to an area endemic for malaria.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Gulf Coast Regional Blood Center Red Blood Cells and Pooled Cryoprecipitated AHF

Red blood cells and pooled cryoprecipitate may have been prepared incorrectly.

Moderate risk, FDA, Ended, Hospital use

4 recalls that day

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a donor screening deviation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98846

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a screening deviation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98845