Medical DeviceApr 24, 2024
Philips Intera 1.0T Omni/Stellar, Magnetic Resonance System recall — FDA Z-1573-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
April 2024 recalls — page 4
These records include useful source details for the selected month.
Medical DeviceApr 24, 2024
Philips Intera 1.5T Achieva IT Nova, Magnetic Resonance System recall — FDA Z-1576-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Outset Medical Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 recall — FDA Z-1485-2024
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated…
Class IFDA: OngoingOutset Medical, Inc.
Medical DeviceApr 24, 2024
SonarMed AW-S025 NEO SONARMED SENSOR 2.5MM recall — FDA Z-1519-2024
The failure to detect the partial obstruction in a 2.5mm sensor.
Class IFDA: OngoingSonarMed Inc.
Medical DeviceApr 24, 2024
Philips Intera 1.5T Achieva Nova, Magnetic Resonance System recall — FDA Z-1577-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
SonarMed AW-S035 NEO SONARMED SENSOR 3.5MM recall — FDA Z-1521-2024
The failure to detect the partial obstruction in a 2.5mm sensor.
Class IFDA: OngoingSonarMed Inc.
Medical DeviceApr 24, 2024
Philips Intera 1.5T, Magnetic Resonance System recall — FDA Z-1575-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips GYROSCAN T5-NT, Magnetic Resonance System recall — FDA Z-1562-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
SonarMed AW-M0001 SONARMED MONITOR recall — FDA Z-1535-2024
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Class IFDA: OngoingSonarMed Inc.
Medical DeviceApr 24, 2024
Actim PROM dipstik, REF 30831ETUS recall — FDA Z-1592-2024
Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.
Class IIFDA: OngoingACTIM OY
Medical DeviceApr 24, 2024
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only recall — FDA Z-1537-2024
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Class IIFDA: OngoingMasimo Corporation
Medical DeviceApr 24, 2024
Philips Achieva 3.0T, Magnetic Resonance System recall — FDA Z-1553-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips Intera 1.5T Omni/Stellar, Magnetic Resonance System recall — FDA Z-1581-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips Achieva 1.5T, Magnetic Resonance System recall — FDA Z-1550-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Unomedical A/S Neria Soft Infusion Set, Product Code 507302, intravascular administration recall — FDA Z-1544-2024
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included…
Class IIFDA: OngoingUnomedical A/S
Medical DeviceApr 24, 2024
Philips Respironics Trilogy Evo Universal Ventilator, all software versions except recall — FDA Z-1505-2024
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceApr 24, 2024
Philips Ingenia 1.5T S, Magnetic Resonance System recall — FDA Z-1565-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
FoodApr 24, 2024
Tropicale Foods Helados Mexico Premium Ice Cream Minis Pack 12 bars recall — FDA F-1178-2024
Salmonella contamination
Class IFDA: TerminatedTropicale Foods, Inc.
FoodApr 24, 2024
HandNatural H&NATURAL TEJOCOTE ROOT TWO PACK 180 PIECES, 6 MONTH SUPPLY recall — FDA F-1160-2024
Product recalled due to the presence of yellow oleander and its components in the product.
Class IFDA: OngoingHandNatural
FoodApr 24, 2024
Cardona Foods Uncooked Tortillas: FTC010 - Flour Tortilla 6 Taco Casa- 18/20 recall — FDA F-1155-2024
Undeclared allergen milk (whey) and undeclared lard
Class IIFDA: TerminatedCardona Foods, Inc.
FoodApr 24, 2024
HandNatural H&NATURAL 2 PACK! BRAZIL SEED 60 PIECES, PURE NATURAL SEMILLA recall — FDA F-1163-2024
Product recalled due to the presence of yellow oleander and its components in the product.
Class IFDA: OngoingHandNatural
FoodApr 24, 2024
Weis Markets, Inc., Ice Cream Division Bakery Item: Angel Creme Filled Powdered Donuts 6 ct recall — FDA F-1150-2024
Foreign material (metal) in donuts
Class IIFDA: TerminatedWeis Markets, Inc., Ice Cream Division
FoodApr 24, 2024
Abdallah Sea Salt Almond Alligators recall — FDA F-1173-2024
Sea Salt Almond Allegator candy has a back label for chocolate covered cherries.
Class IIIFDA: TerminatedAbdallah Inc.
FoodApr 24, 2024
HandNatural H&NATURAL BRAZIL SEED 30 PIECES, PURE NATURAL SEMILLA DE recall — FDA F-1166-2024
Product recalled due to the presence of yellow oleander and its components in the product.
Class IFDA: OngoingHandNatural
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.