DrugJan 25, 2023
Akorn Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle recall — FDA D-0141-2023
CGMP Deviations:
Class IIFDA: OngoingAkorn, Inc.
January 2023 recalls — page 4
These records include useful source details for the selected month.
DrugJan 25, 2023
Southwest Iowa Renewable Energy SIREtizer Hand Sanitizer (Ethyl Alcohol) 80% recall — FDA D-0166-2023
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Class IIFDA: OngoingSouthwest Iowa Renewable Energy LLC
DrugJan 25, 2023
Accord Healthcare Daptomycin for Injection 350 mg/vial 1 Single-dose vial recall — FDA D-0131-2023
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Class IFDA: TerminatedAccord Healthcare, Inc.
DrugJan 25, 2023
Fisher Scientific Co Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v recall — FDA D-0163-2023
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary…
Class IIFDA: OngoingFisher Scientific Co., LLC
VehicleJan 23, 2023
Ford camera recall — NHTSA campaign 23V022000
Ford Motor Company (Ford) is recalling certain 2020-2023 Explorer, Lincoln Aviator, and 2020-2022 Lincoln Corsair vehicles equipped with a 360-degree camera. The video output may fail,…
cameraFord Motor Company
VehicleJan 19, 2023
Volvo Car USA hydraulic brakes recall — NHTSA campaign 23V012000
Volvo Car USA, LLC (Volvo Car) is recalling certain 2023 S60, V60, V60CC, V90CC, XC60, XC90, XC40, and C40 vehicles. A diagnostic error in the Brake Control Module 2 (BCM2) may cause a loss…
hydraulic brakesVolvo Car USA, LLC
VehicleJan 19, 2023
General Motors control/drive module recall — NHTSA campaign 23V013000
General Motors, LLC (GM) is recalling certain 2021-2022 Chevrolet Equinox and 2022 GMC Terrain vehicles. The fuel pump module may not consistently provide sufficient fuel to the engine,…
control/drive moduleGeneral Motors, LLC
Medical DeviceJan 18, 2023
Stradis Healthcare HCT CENTRAL LINE Insertion Tray, I2 per case recall — FDA Z-0940-2023
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class IIFDA: OngoingStradis Healthcare
Medical DeviceJan 18, 2023
Stradis Healthcare HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 recall — FDA Z-0936-2023
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Class IIFDA: OngoingStradis Healthcare
Medical DeviceJan 18, 2023
Philips Garbin Ventilator, Model Number 1058180B recall — FDA Z-0884-2023
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen,…
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceJan 18, 2023
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring recall — FDA Z-0908-2023
Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceJan 18, 2023
Siemens Healthcare Diagnostics IMMULITE 2000 Thyroglobulin (OUS) recall — FDA Z-0950-2023
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceJan 18, 2023
Bayer Medical Care Source Administration Set (SAS) used with the Medrad Intego PET Infusion recall — FDA Z-0910-2023
Black specks may be present on the packaged needles
Class IIFDA: OngoingBayer Medical Care, Inc.
Medical DeviceJan 18, 2023
The Anspach Effort Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone recall — FDA Z-0918-2023
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow…
Class IIFDA: OngoingThe Anspach Effort, Inc.
Medical DeviceJan 18, 2023
Medline CISION Sterile Blades recall — FDA Z-0930-2023
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceJan 18, 2023
Depuy Ireland UC BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 recall — FDA Z-0951-2023
All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory…
Class IIFDA: OngoingDepuy Ireland UC
Medical DeviceJan 18, 2023
The Anspach Effort 6.5 cm Adult Rotating Craniotome Attachment recall — FDA Z-0916-2023
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow…
Class IIFDA: OngoingThe Anspach Effort, Inc.
Medical DeviceJan 18, 2023
The Anspach Effort 6.5 cm Adult Craniotome, Thin Foot Plate Attachment recall — FDA Z-0917-2023
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow…
Class IIFDA: OngoingThe Anspach Effort, Inc.
Medical DeviceJan 18, 2023
The Anspach Effort 6.5 cm Adult Rotating Craniotome Attachment recall — FDA Z-0919-2023
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow…
Class IIFDA: OngoingThe Anspach Effort, Inc.
Medical DeviceJan 18, 2023
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B recall — FDA Z-0883-2023
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen,…
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceJan 18, 2023
The Anspach Effort 7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax recall — FDA Z-0920-2023
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow…
Class IIFDA: OngoingThe Anspach Effort, Inc.
Medical DeviceJan 18, 2023
CareFusion 303 BD Pyxis MedBank System - Product Label/labeling pending recall — FDA Z-0928-2023
Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on…
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceJan 18, 2023
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA recall — FDA Z-0907-2023
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining…
Class IIFDA: OngoingVentana Medical Systems, Inc.
Medical DeviceJan 18, 2023
Medtronic Navigation RadiaLux Lighted Retractor (Pink), REF: 50-101-1 recall — FDA Z-0953-2023
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
Class IIFDA: OngoingMedtronic Navigation, 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.