Delaware recalls

Philips MX40 patient monitors may lose wireless connection to the PIC iX central station when moving between certain access points if the signal strength changes rapidly. This could interrupt patient data transmission to clinical staff.

Securitas Healthcare identified a firmware problem in certain Arial 900 MHz Call Station units (Model CSK200-900MR, Firmware 1.6.3) sold between January 2023 and June 2024. The affected units may fail to send a low battery alert to the wireless system before the battery dies, or may not send the alert at least 7 days in advance as designed. This could leave the call station without power when someone needs to use it.

A firmware issue in certain Securitas Healthcare Arial 900 MHz call stations (Model CSK200-900) may prevent them from sending low battery warnings to the wireless system. This means the device could lose power without giving you advance notice. The affected units were sold between January 1, 2023 and June 26, 2024.

Abiomed has recalled 2 units of the Impella 5.5 with SmartAssist S2 heart pump device because the devices were shipped in incorrect outer box cartons. This packaging error may affect proper device identification and handling. No injuries have been reported.

Sophysa's Pressio 2 ICP Monitoring System (Model PSO-4000) may unexpectedly reboot during use. This device is used in hospitals to measure pressure inside the skull. The reboots could interrupt critical monitoring of patients.

A software issue in certain BD Pyxis ES Enterprise Server systems may prevent timely updates of patient, medication, and related information from reaching the dispensing cabinets. This could delay access to critical data in healthcare settings. BD and the FDA are working to address the problem.

Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.

Beckman Coulter UniCel Dxl 800 analyzers (part numbers 973100, A71456, A71457, A25288) may fail to restart after shutdown due to a communication issue. When this happens, the analyzer cannot initialize or process patient samples, QCs, or calibrators, which delays test results.

Certain Beckman Coulter UniCel DxL 600 analyzers may fail to restart properly after shutdown due to a communication issue. When this happens, the analyzer cannot process patient samples or quality control checks, which can delay test results.

Meridian Bioscience's Revogene C. difficile diagnostic test (a lab assay used with the Revogene instrument) may show declining accuracy over time in certain lots. This could produce false-negative results, meaning the test might not detect C. difficile infection when it is present.

Roche Diagnostics has recalled certain lots of the Elecsys Anti-TSHR blood test due to inconsistent results across different laboratory instruments and variations between calibrator batches. These issues could lead to incorrect or delayed thyroid diagnosis and treatment.

Philips Healthcare has recalled certain Incisive CT scanners due to an unstable internal connection in the floating sensor. This instability may cause the scanner to produce incomplete or compromised scans. The issue affects 35 devices distributed across the U.S. and its territories, and no injuries have been reported.

AVID Medical is recalling the Halyard MINI PLUS KIT SOUTH (Kit Code JACK097-08) because the devices are not suitable for organ transplant procedures. The recall affects 380 units distributed in Florida, Georgia, and Puerto Rico.

Halyard's ORGAN RECOVERY OR PACK (Kit Code LLOF1000-17) is not suitable for organ transplant procedures. The FDA has classified this as a Class I recall, the most serious type. A total of 52 units were distributed in Florida, Georgia, and Puerto Rico.

Halyard ORGAN RECOVERY OR PACK (Kit Code LLOG1000-15) devices have been found to be unsuitable for organ transplant use. The FDA has issued a Class I recall affecting 132 units distributed in Florida, Georgia, and Puerto Rico. No injuries have been reported.

Siemens LUMINOS Lotus Max and Luminos dRF Max X-ray systems with software version VF11 may show incorrect collimation (beam positioning) when quickly switching between organ programs. This affects only systems with a bucky wall stand for mobile detectors and no ceiling stand.

Vision RT identified that instructions for the AlignRT InBore radiation therapy system omitted required information about its six Class 1 lasers and their specifications. The missing details are required by federal laser safety regulations. No injuries have been reported.

Bengal King Jhal Chanachur food treats (12.34 oz packages) contain peanuts that are not listed on the label. This poses a serious risk to anyone with a peanut allergy. The affected product has lot number HCNCU1205/24 and an expiration date of June 2026.

MAYEJ Italian Parsley packaged in 24lb boxes has been recalled due to potential contamination with Cyclospora cayetanensis, a parasite that can cause foodborne illness. About 1,288 boxes were distributed nationwide. No illnesses have been reported so far.

Ziyad Brothers Importing is recalling Baraka Gourmet Pastry Kunafe (6.7 oz) because it may contain partially hydrogenated oils that are not listed on the label. Partially hydrogenated oils contain trans fats, which are not permitted in food sold in the United States. No injuries have been reported.

Ziyad Brothers Importing is recalling Baraka French Style Puff Pastry in 1lb and 1.5lb sizes because they may contain partially hydrogenated oils that are not listed on the label. Partially hydrogenated oils are banned in most foods in the United States. No injuries have been reported.

Locatelli Grated Pecorino Romano cheese in 8 oz plastic cups has been recalled because it tested positive for Listeria Monocytogenes, a bacteria that can cause serious illness. The affected product was distributed across multiple states in the U.S.

Ambriola Co., Inc. is recalling grated Pecorino Romano cheese in 5 and 10-pound bags because the product tested positive for Listeria monocytogenes, a bacteria that can cause serious illness. The recalled cheese was distributed across multiple states.

Boar's Head Pecorino Romano Grated cheese in 5-pound bags tested positive for Listeria monocytogenes, a bacterium that can cause serious illness. The affected product was distributed across multiple states. No illnesses have been reported so far.

Sam's Pecorino Romano grated cheese in 1.5 lb plastic bags tested positive for Listeria Monocytogenes, a bacteria that can cause serious illness. The affected product was distributed across multiple states. No illnesses have been reported to date.

Boar's Head grated Pecorino Romano cheese in 6 oz cups tested positive for Listeria monocytogenes, a bacteria that can cause serious illness. The affected product has lot number 1000572486 and was distributed across multiple states.

Pinna Grated Pecorino Romano cheese in 10-pound bags tested positive for Listeria Monocytogenes, a bacteria that can cause serious illness. The affected product was distributed across multiple states. No illnesses have been reported so far.

Locatelli Grated Pecorino Romano cheese in 5 and 10-pound bags tested positive for Listeria monocytogenes, a bacterium that can cause serious illness. The affected product was distributed across 20 states. No illnesses have been reported so far.

Locatelli Grated Pecorino Romano cheese in 4 oz and 8 oz plastic cups tested positive for Listeria Monocytogenes, a bacteria that can cause serious illness. The affected product was distributed across multiple U.S. states.

Sam Dry Fruits & Nuts Enterprises is recalling whole pistachio meats (Lot #PK00459, 30-lb bags, pack date August 2025) because they may be contaminated with Salmonella, a bacteria that can cause serious illness. This is a Class I recall, the most serious type. No illnesses have been reported so far.