Medical DeviceMay 29, 2024
MEDLINE SYR 5ML L/L WHITE recall — FDA Z-2060-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
May 2024 recalls — page 6
These records include useful source details for the selected month.
Medical DeviceMay 29, 2024
Fresenius Medical Care Holdings 2008T BlueStar Hemodialysis Machine, Model 191126 with recall — FDA Z-1868-2024
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
Medical DeviceMay 29, 2024
MEDLINE SYR 20ML L/L BLUE SALINE recall — FDA Z-2075-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a recall — FDA Z-1873-2024
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Class IIFDA: OngoingIntegra LifeSciences Corp.
Medical DeviceMay 29, 2024
Philips Evolution upgrade 3.0T Model Number (REF): (1)782117 recall — FDA Z-1844-2024
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 29, 2024
Philips SmartPath to dStream for 3.0T Model Number (REF): 782145 recall — FDA Z-1861-2024
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 29, 2024
Philips Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems recall — FDA Z-1851-2024
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 29, 2024
Philips Ingenia Ambition S Model Number (REF): (1) 782139 recall — FDA Z-1850-2024
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 29, 2024
Philips Respironics BiPAP V30 Auto Ventilator, Part Number 1111178 recall — FDA Z-1812-2024
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory…
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceMay 29, 2024
MEDLINE SYR 20ML L/L GREEN recall — FDA Z-2068-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
Philips MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical recall — FDA Z-1857-2024
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 29, 2024
MEDLINE SYR 20ML L/L YELLOW recall — FDA Z-2071-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR CNTRL 10ML L/L RED recall — FDA Z-2096-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
Merit Medical Systems Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 recall — FDA Z-1874-2024
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceMay 29, 2024
MEDLINE SYR 60ML L/S recall — FDA Z-2044-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
Wolf Medical 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC recall — FDA Z-2104-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
Philips Achieva 3.0T Model Number (REF): (1) 781345 recall — FDA Z-1839-2024
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 29, 2024
GMAX SYR 35ML/LL syringe recall — FDA Z-2115-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 10ML L/L PURPLE recall — FDA Z-2074-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 10ML L/L RED recall — FDA Z-2062-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
MEDLINE SYR 10ML L/L GREEN recall — FDA Z-2063-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
Medical DeviceMay 29, 2024
GMAX SYR 5ML/LL syringe recall — FDA Z-2124-2024
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class IIFDA: OngoingJiangsu Shenli Medical Production Co., Ltd.
FoodMay 29, 2024
Tama Queso de mano, Fresh soft white cheese, NET WT 24 oz recall — FDA F-1262-2024
Potential contamination with Listeria Monocytogenes
Class IFDA: TerminatedTama Corporation
FoodMay 29, 2024
Graceleigh, Inc. dba Sammy's Milk Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz recall — FDA F-1247-2024
FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe for…
Class IFDA: TerminatedGraceleigh, Inc. dba Sammy's Milk
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.