Medical DeviceOct 18, 2023
Ansell Healthcare Products NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF recall — FDA Z-0097-2024
Some surgical glove sterile pouches were not completely sealed.
Class IIFDA: OngoingAnsell Healthcare Products LLC
October 2023 recalls — page 3
These records include useful source details for the selected month.
Medical DeviceOct 18, 2023
RoyalVibe Health CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound recall — FDA Z-0082-2024
Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of customers'…
Class IIFDA: OngoingRoyalVibe Health Ltd.
Medical DeviceOct 18, 2023
Alcon Research Constellation Vision System, REF: 8065751150 recall — FDA Z-0099-2024
Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of…
Class IIFDA: OngoingAlcon Research, LLC
Medical DeviceOct 18, 2023
Encore Medical REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long recall — FDA Z-0098-2024
Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceOct 18, 2023
Cardinal Health 200 Procedure pack: Presource PBDS, Cat recall — FDA Z-0085-2024
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceOct 18, 2023
TECHNO-PATH MANUFACTURING Multichem P, Part Code 08P90-10 recall — FDA Z-0106-2024
Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem…
Class IIFDA: OngoingTECHNO-PATH MANUFACTURING LTD.
Medical DeviceOct 18, 2023
Cardinal Health 200 Procedure pack: Presource PBDS Cat recall — FDA Z-0090-2024
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Class IIFDA: OngoingCardinal Health 200, LLC
FoodOct 18, 2023
The Little Oak Company LittleOak Natural Goat Milk Infant Formula recall — FDA F-0008-2024
No pre-market notification and Mixing instructions not in ounces
Class IIFDA: TerminatedThe Little Oak Company Ltd
FoodOct 18, 2023
Fairfield Gourmet Food Corp d/b/a David's Markside Ultimate Peanut Butter Chocolate Cake, 7 recall — FDA F-0010-2024
Fairfield Gourmet Food Corp. d/b/a David s Cookies ,28 Industrial Road, Fairfield NJ 07004has initiated a recall of Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g) plastic…
Class IIFDA: TerminatedFairfield Gourmet Food Corp d/b/a David's Cookies
FoodOct 18, 2023
Infinant Health Evivo with MCT Oil Infant Probiotic Activated B recall — FDA F-0299-2024
Unapproved food additive.
Class IIFDA: TerminatedInfinant Health, LLC
FoodOct 18, 2023
The Little Oak Company LittleOak Natural Goat Milk Follow On Infant Formula recall — FDA F-0009-2024
No pre-market notification and Mixing instructions not in ounces
Class IIFDA: TerminatedThe Little Oak Company Ltd
FoodOct 18, 2023
Maisie Jane's California Sunshine Products 12 oz glass jar, 6 units per case, shelf stable recall — FDA F-0012-2024
High levels of aflatoxin
Class IIFDA: TerminatedMaisie Jane's California Sunshine Products Inc.
DrugOct 18, 2023
Scynexis BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons recall — FDA D-0042-2024
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Class IFDA: CompletedScynexis, Inc.
VehicleOct 13, 2023
Explorer display function recall — NHTSA campaign 23V686000
Ford Motor Company (Ford) is recalling certain 2023 Explorer vehicles equipped with a standard rearview camera. Due to a manufacturing error in the wire harness, the rearview camera may…
display functionFord Motor Company
VehicleOct 12, 2023
General Motors windshield recall — NHTSA campaign 23V681000
General Motors, LLC (GM) is recalling certain 2023 GMC Acadia and 2024 Cadilac XT5 and XT6 vehicles. The windshield may have been assembled without the proper urethane sealant required to…
windshieldGeneral Motors, LLC
VehicleOct 12, 2023
Toyota 4Runner labels recall — NHTSA campaign 23V680000
Southeast Toyota Distributors, LLC (SET) is recalling certain 2023 Toyota 4Runner vehicles. The load carrying capacity modification label states the incorrect load carrying capacity, which…
labelsSoutheast Toyota Distributors, LLC
Medical DeviceOct 11, 2023
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A recall — FDA Z-0003-2024
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Class IFDA: OngoingARROW INTERNATIONAL Inc.
Medical DeviceOct 11, 2023
Getinge Usa Sales Meera Mobile Operating Table-to support and position the patient recall — FDA Z-0036-2024
Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an…
Class IIFDA: OngoingGetinge Usa Sales Inc.
Medical DeviceOct 11, 2023
Boston Scientific Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number recall — FDA Z-0010-2024
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 11, 2023
AB Sciex Citrine QTRAP Mass Spectrometer, Part Number 5063685 recall — FDA Z-0039-2024
In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible…
Class IIFDA: OngoingAB Sciex, LLC
Medical DeviceOct 11, 2023
Zimmer Dermatome Blades- 10-pack boxes of blades recall — FDA Z-0069-2024
Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the…
Class IIFDA: OngoingZimmer Surgical Inc.
Medical DeviceOct 11, 2023
Ortho-Clinical Diagnostics Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS recall — FDA Z-0008-2024
Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Medical DeviceOct 11, 2023
Boston Scientific Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number recall — FDA Z-0017-2024
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceOct 11, 2023
Boston Scientific Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number recall — FDA Z-0018-2024
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip…
Class IIFDA: OngoingBoston Scientific Corporation
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.