Wegmans Food Markets, Inc. Recalls

FDAApr 25, 2024NY, PA• Wegmans Food Markets, Inc.

MNA-420 ENC HDMI (Barco) – SFP+ Module Issue (2024)

We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances, this connection may render the first HDMI channel inaccessible, making both the channel and the respective MNA ENC unit unusable. Additionally, readings from the module become unavailable when this issue arises. Similarly, when this Molex module is connected to the ETH0 slot of an MNA-620 ENC ANA, readings may also become inaccessible.

Low

FDAApr 24, 2024FL• Barco N.V. President Kennedypark 35 Kortrijk Belgium

EasySuite 4K Operating Room System (Olympus) – Testing Records (2024)

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A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits

Low

FDAApr 24, 2024Nationwide• Olympus Corporation of the Americas

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Discoloration: Dotted and yellow spots on tablets

FDAApr 24, 2024Nationwide• Aurobindo Pharma USA Inc.

Progesterone Tablets (Anazao) – Metal Fragment (2024)

Presence of Foreign Substance; Broken metal piece found embedded in tablet.

FDAApr 24, 2024Nationwide• Coast Quality Pharmacy, LLC dba Anazao Health

Sodium Sulfacetamide Cleanser (Acella) – Subpotent Drug (2024)

Subpotent drug

Class IIILow

FDAApr 24, 2024Nationwide• Acella Pharmaceuticals, LLC

Cefdinir Suspension (Lupin) – Foreign Material (2024)

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

FDAApr 24, 2024Nationwide• Lupin Pharmaceuticals Inc.

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Discoloration: Dotted and yellow spots on tablets

FDAApr 24, 2024Nationwide• Aurobindo Pharma USA Inc.

Cefdinir Suspension (Lupin) – Foreign Material (2024)

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

FDAApr 24, 2024Nationwide• Lupin Pharmaceuticals Inc.

Queso de Mano (Tama Corporation) – Listeria Contamination (2024)

Listeria

Potential contamination with Listeria Monocytogenes

Class IHigh

FDAApr 24, 2024IN, UT• Tama Corporation

Monoject Syringe (McKesson) – Distribution Error (2024)

Quarantined product was inadvertently distributed

Low

FDAApr 23, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

EYLEA Injection (Regeneron) – Syringe Breakage (2024)

Lack of Assurance of Sterility: Complaints of syringe breakage

FDAApr 23, 2024Nationwide• Regeneron Pharmaceuticals Inc

Prucka 3 Amplifier (GE Medical) – capacitor failure (2024)

Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.

Moderate

FDAApr 22, 2024Nationwide• GE Medical Systems Information Technologies Inc

Ingenia 3.0T MRI System (Philips) – ventilation warning issue (2024)

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation

FDAApr 22, 2024Nationwide• Philips North America Llc

Xelpros (Sun Pharmaceutical) – Failed Particulate Test (2024)

Failed Release Testing: Out of specification for particulate matter test.

Class IIILow

FDAApr 22, 2024PA, TX• SUN PHARMACEUTICAL INDUSTRIES INC

Ingenia 1.5T MRI System (Philips) – ventilation warning issue (2024)

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation

FDAApr 22, 2024Nationwide• Philips North America Llc

Tirzepatide (Revive Rx) – Labeling Mix-up (2024)

Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate

Class IHigh

FDAApr 20, 2024Nationwide• Revive Rx LLC dba Revive Rx Pharmacy

Patient Information Center iX (Philips) – data transfer problem (2024)

Event Catalog information does not save when copied and transferred from one unit to another.

Low

FDAApr 19, 2024Nationwide• Philips North America Llc

Coachmen Catalina (Coachmen) – appliance panel problem (2024)

Forest River, Inc. (Forest River) is recalling certain 2024 Coachmen Catalina BCAT154RDX and Forest River Aurora BART15RDX travel trailers. The panel that isolates the cooktop from the furnace was not properly sealed during manufacturing, which could result in an inverted cooktop flame.

NHTSAApr 19, 2024Nationwide• COACHMEN

REV Ambulance Type IX (REV Ambulance) – electrical system issue (2024)

REV Ambulance Group Orlando, Inc. (REV) is recalling certain 2019-2024 Type I, Type III, and Type IX vehicles equipped with certain Weldon Vmux HC1.7 Input/Output multiplex nodes. In the event of a short circuit or wiring failure, the firmware in the node may fail to shut off the output pin, resulting in overloaded electrical circuits.