DrugDec 14, 2022
RemedyRepack Desmopressin Acetate Tablet, 0.2 mg, 100-count box recall — FDA D-0077-2023
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Class IIFDA: TerminatedRemedyRepack Inc.
December 2022 recalls — page 13
These records include useful source details for the selected month.
DrugDec 14, 2022
SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE recall — FDA D-0075-2023
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
VehicleDec 14, 2022
Bronco side impact recall — NHTSA campaign 22V928000
Ford Motor Company (Ford) is recalling certain 2021-2022 Bronco vehicles. The right or left side impact sensors may not be properly secured to the vehicle.
side impactFord Motor Company
VehicleDec 14, 2022
Chevrolet Malibu frame and members recall — NHTSA campaign 22V923000
General Motors, LLC (GM) is recalling certain 2022-2023 Chevrolet Malibu vehicles. The front impact bar, a structural portion of the vehicle frame, may not be properly welded to the front…
frame and membersGeneral Motors, LLC
VehicleDec 8, 2022
Forte arm recall — NHTSA campaign 22V906000
Kia America, Inc. (Kia) is recalling certain 2023 Forte vehicles. Due to a manufacturing error, the front left steering knuckle may crack, which can result in a loss of steering control.
armKia America, Inc.
VehicleDec 8, 2022
General Motors lighting control module software recall — NHTSA campaign 22V903000
General Motors, LLC (GM) is recalling certain 2020-2023 Cadillac CT4 and CT5; 2021-2023 Buick Envision; and 2022-2023 Cadillac Escalade and Escalade ESV, Chevrolet Silverado 1500, Suburban,…
lighting control module softwareGeneral Motors, LLC
VehicleDec 8, 2022
Chrysler hinge and attachments recall — NHTSA campaign 22V904000
Chrysler (FCA US, LLC) is recalling certain 2019-2022 Ram 1500, 2500, and 3500 pickup trucks. The tailgate may not latch properly due to misaligned tailgate strikers, which could result in…
hinge and attachmentsChrysler (FCA US, LLC)
VehicleDec 8, 2022
Ascent interior/under dash recall — NHTSA campaign 22V907000
Subaru of America, Inc. (Subaru) is recalling certain 2019-2022 Ascent vehicles. The ground bolt that secures the ground terminal of the Positive Temperature Coefficient (PTC) heater may…
interior/under dashSubaru of America, Inc.
Medical DeviceDec 7, 2022
Bio-Rad Laboratories CMV IgM EIA, in vitro diagnostic recall — FDA Z-0342-2023
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Class IIFDA: OngoingBio-Rad Laboratories, Inc.
Medical DeviceDec 7, 2022
Owens & Minor Distribution Aero Blue Performance Surgical Gown, XL- Sterile surgical gown recall — FDA Z-0343-2023
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
Class IIFDA: OngoingOwens & Minor Distribution, Inc.
Medical DeviceDec 7, 2022
GREER DIA - KIT ANTIGEN M recall — FDA Z-0348-2023
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was…
Class IIFDA: TerminatedGreer Laboratories, Inc.
Medical DeviceDec 7, 2022
Primus Corporation dba Trinity Biotech Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL recall — FDA Z-0350-2023
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable…
Class IIIFDA: TerminatedPrimus Corporation dba Trinity Biotech
Medical DeviceDec 7, 2022
Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 recall — FDA Z-0326-2023
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
Class IIFDA: OngoingBusse Hospital Disposables, Inc.
Medical DeviceDec 7, 2022
Alcon Custom Pak Surgical Procedure Pack recall — FDA Z-0354-2023
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has…
Class IIFDA: OngoingAlcon Research, LLC
Medical DeviceDec 7, 2022
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy recall — FDA Z-0353-2023
Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the…
Class IIFDA: TerminatedCytocell Ltd.
Medical DeviceDec 7, 2022
Accelerate PhenoTest BC kit REF 10102018 recall — FDA Z-0346-2023
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and…
Class IIFDA: OngoingAccelerate Diagnostics Inc.
Medical DeviceDec 7, 2022
GS Biomark CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200 recall — FDA Z-0324-2023
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
Class IIFDA: OngoingGS Biomark LLC
Medical DeviceDec 7, 2022
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782 recall — FDA Z-0341-2023
An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong…
Class IIFDA: TerminatedCytocell Ltd.
Medical DeviceDec 7, 2022
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE recall — FDA Z-0340-2023
Potential staple deployment failure and device fragment generation
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceDec 7, 2022
Primus Corporation dba Trinity Biotech A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1 recall — FDA Z-0349-2023
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results…
Class IIIFDA: TerminatedPrimus Corporation dba Trinity Biotech
Medical DeviceDec 7, 2022
Mobius Imaging MobiCT-32 AIRO Mobile CT Scanner, Cat recall — FDA Z-0344-2023
Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems…
Class IIFDA: TerminatedMobius Imaging, LLC
Medical DeviceDec 7, 2022
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY recall — FDA Z-0347-2023
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was…
Class IIFDA: TerminatedGreer Laboratories, Inc.
Medical DeviceDec 7, 2022
Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 recall — FDA Z-0325-2023
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
Class IIFDA: OngoingBusse Hospital Disposables, Inc.
Medical DeviceDec 7, 2022
Accelerate PhenoTest BC kit REF 10101018 recall — FDA Z-0345-2023
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and…
Class IIFDA: OngoingAccelerate Diagnostics 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.