Medical DeviceDec 21, 2022
DeRoyal MYELOGRAM PACK, REF 89-9304.06 recall — FDA Z-0648-2023
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class IIFDA: OngoingDeRoyal Industries Inc.
December 2022 recalls — page 8
These records include useful source details for the selected month.
Medical DeviceDec 21, 2022
DeRoyal Industries GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13 recall — FDA Z-0567-2023
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class IIFDA: OngoingDeRoyal Industries Inc.
Medical DeviceDec 21, 2022
Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787 recall — FDA Z-0517-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Novasure Pack, Item No.570-1462 recall — FDA Z-0504-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, BASIC PACK, Item No.570-2719 recall — FDA Z-0512-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
DeRoyal Industries GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09 recall — FDA Z-0572-2023
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class IIFDA: OngoingDeRoyal Industries Inc.
Medical DeviceDec 21, 2022
Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Basin Set, Item No.570-1803 recall — FDA Z-0508-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
Becton Dickinson & Co BBL Chocolate II Agar- IVD for the isolation and cultivation of recall — FDA Z-0473-2023
Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could…
Class IIFDA: OngoingBecton Dickinson & Co.
Medical DeviceDec 21, 2022
STRADIS HEALTHCARE, Surgery PK, Item No.682-1728 recall — FDA Z-0542-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15 recall — FDA Z-0560-2023
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class IIFDA: OngoingDeRoyal Industries Inc.
Medical DeviceDec 21, 2022
Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, LOOP RECORDER PACK, Item recall — FDA Z-0522-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, SURGICAL PAIN TRAY, Item recall — FDA Z-0505-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1 recall — FDA Z-0546-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
DeRoyal CATARACT PACK CSM, REF 89-6863 recall — FDA Z-0580-2023
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class IIFDA: OngoingDeRoyal Industries Inc.
Medical DeviceDec 21, 2022
Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item recall — FDA Z-0530-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray recall — FDA Z-0490-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
STRADIS HEALTHCARE, Angioplasty, Item No.682-1937 recall — FDA Z-0544-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
Medical DeviceDec 21, 2022
Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Vas Reversal Pack, Item recall — FDA Z-0557-2023
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the…
Class IIFDA: OngoingStradis Medical, LLC dba Stradis Healthcare
FoodDec 21, 2022
St. Jean's Coast Mountain Resources Ltd. (dba) Sardines in tomato sauce packed in cans recall — FDA F-0195-2023
Canned sardines in tomato sauce recalled due to high levels of histamine.
Class IIFDA: TerminatedSt. Jean's Coast Mountain Resources Ltd. (dba) St.…
DrugDec 21, 2022
BayCare Integrated Service Center, LLC /dba Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml recall — FDA D-0086-2023
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Class IFDA: TerminatedBayCare Integrated Service Center, LLC /dba BayCare…
DrugDec 21, 2022
SODIUM BICARBONATE 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL recall — FDA D-0079-2023
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class IFDA: TerminatedExela Pharma Sciences LLC
DrugDec 21, 2022
Exela Pharma Sciences 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL recall — FDA D-0080-2023
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class IFDA: TerminatedExela Pharma Sciences LLC
DrugDec 21, 2022
Lacosamide Oral Solution, USP, CV, 10mg/mL recall — FDA D-0094-2023
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Class IIIFDA: TerminatedCamber Pharmaceuticals, Inc.
VehicleDec 19, 2022
BMW critical fasteners recall — NHTSA campaign 22V942000
BMW of North America, LLC (BMW) is recalling certain 2023 X5 sDrive40i, X5 M50i and X5 xDrive 45e vehicles. One of the four bolts that connects the backrest to the driver's seat frame may…
critical fastenersBMW of North America, LLC
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.