Medical DeviceMar 24, 2021
Medline Industries RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage recall — FDA Z-1249-2021
Product was compromised during shipment.
Class IIFDA: TerminatedMedline Industries Inc.
March 2021 recalls — page 4
These records include useful source details for the selected month.
Medical DeviceMar 24, 2021
Epimed International Feth-R-Kath Catheter, 19g x 24" recall — FDA Z-1276-2021
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Class IIFDA: TerminatedEpimed International, Inc.
Medical DeviceMar 24, 2021
Cardinal Health 200 JUDKINS PACK recall — FDA Z-1256-2021
Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceMar 24, 2021
Accuray CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided recall — FDA Z-1272-2021
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
Class IIFDA: TerminatedAccuray Inc.
Medical DeviceMar 24, 2021
Ortho-Clinical Diagnostics VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS recall — FDA Z-1267-2021
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
Class IIFDA: TerminatedOrtho-Clinical Diagnostics, Inc.
FoodMar 24, 2021
Seafood Imports Distributors Java Frozen Tuna Steaks - 10 oz recall — FDA F-0339-2021
FDA Sample found Salmonella in one lot of 10 oz. frozen tuna steaks.
Class IFDA: TerminatedSeafood Imports Distributors Inc.
FoodMar 24, 2021
Laboratorios Pisa Sa De Cv Electrolit Ponche/Fruit Punch recall — FDA F-0363-2021
Product contains undeclared FD&C Red No. 40.
Class IIIFDA: TerminatedLaboratorios Pisa Sa De Cv
FoodMar 24, 2021
Laboratorios Pisa Sa De Cv Electrolit Fruit Punch Zero, 625ML/21OZ packaged in a recall — FDA F-0364-2021
Product contains undeclared FD&C Red No. 40.
Class IIIFDA: TerminatedLaboratorios Pisa Sa De Cv
FoodMar 24, 2021
Flying Food Group Amazon Kitchen, Avocado Chicken Salad Sandwich, Net Wt recall — FDA F-0381-2021
Flying Food Group, LLC , initiated a recall of Amazon Kitchen Avocado Chicken Salad Sandwich . The soy allergen is undeclared on the finish product label. The label does have the following…
Class IFDA: TerminatedFlying Food Group LLC
FoodMar 24, 2021
KAREEM MART Tahina Sesame Paste packaged in 1lb and 2lb plastic jars and recall — FDA F-0341-2021
Product tested positive for Salmonella.
Class IFDA: TerminatedKAREEM MART Inc.
DrugMar 24, 2021
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial recall — FDA D-0305-2021
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class IIFDA: TerminatedSagent Pharmaceuticals Inc.
DrugMar 24, 2021
Edge Pharma Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution recall — FDA D-0306-2021
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Class IIIFDA: TerminatedEdge Pharma, LLC
DrugMar 24, 2021
Bryant Ranch Prepack, Inc. dba BRP Spironolactone Tablets, USP, 25 mg recall — FDA D-0303-2021
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Class IFDA: OngoingBryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
DrugMar 24, 2021
Direct Rx Nortriptyline HCL capsules, 10 mg recall — FDA D-0300-2021
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally…
Class IIFDA: TerminatedDirect Rx
DrugMar 24, 2021
Breckenridge Pharmaceutical Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count recall — FDA D-0308-2021
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Class IIFDA: TerminatedBreckenridge Pharmaceutical, Inc.
DrugMar 24, 2021
Akorn Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per recall — FDA D-0301-2021
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class IIFDA: TerminatedAkorn, Inc.
DrugMar 24, 2021
Bryant Ranch Prepack, Inc. dba BRP Spironolactone Tablets, USP, 50 mg recall — FDA D-0304-2021
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Class IIFDA: OngoingBryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
VehicleMar 18, 2021
General Motors seat belts recall — NHTSA campaign 21V190000
General Motors, LLC (GM) is recalling certain 2021 Cadillac Escalade, Escalade ESV, GMC Yukon, Yukon XL, Chevrolet Suburban, and Tahoe vehicles with third-row seating. The third-row…
seat beltsGeneral Motors, LLC
Medical DeviceMar 17, 2021
Howmedica Osteonics Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented recall — FDA Z-1186-2021
Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number…
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceMar 17, 2021
Brainlab AG ExacTrac Dynamic recall — FDA Z-1185-2021
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may…
Class IIFDA: TerminatedBrainlab AG
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material recall — FDA Z-1237-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material recall — FDA Z-1207-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material recall — FDA Z-1214-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 recall — FDA Z-1182-2021
The product may be contaminated with Burkholderia cepacia
Class IIFDA: TerminatedSunstar Americas, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.