New Mexico recalls

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.

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.

McCain Foods USA Inc is recalling Sysco Imperial Potato Tater Barrel frozen potatoes because some packages may contain hard plastic fragments. The affected product was distributed across 26 states in specific batch codes produced in October and November 2025. No injuries have been reported.

Ore-Ida Tater Tots shaped potatoes (item OIF00215A, 30 lb cases) may contain clear hard plastic fragments. The affected product was produced between October 9–14, 2027, and distributed to foodservice locations across 27 states. No injuries have been reported.

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.

AvKARE is recalling Rosuvastatin 10 mg tablets (Lot #49124, expiring 12/31/2026) because they don't dissolve properly in the body. This means the medication may not work as intended. No injuries have been reported so far.

ClearLife Allergy Nasal Spray Extra Strength has been found to contain yeast, mold, and a bacterium called Achromobacter. The contamination affects all batches still within their expiration date sold nationwide. No injuries have been reported so far.

MediNatura ReBoost Nasal Spray has been found to contain yeast, mold, and a bacterium called Achromobacter. These contaminants should not be in a nasal spray, which is meant to be sterile. The contamination affects all lots currently in use.

SpecGx LLC is recalling one lot of oxycodone and acetaminophen tablets (7.5 mg/325 mg) because some tablets may be missing the imprint (identifying mark). This makes it difficult to verify you have the correct medication. No injuries have been reported.

SpecGx LLC is recalling certain bottles of oxycodone and acetaminophen 10mg/325mg tablets because some tablets may be missing the imprint (marking). This could make it difficult to identify the medication. No injuries have been reported.

Imprimis NJOF recalled Tri-Moxi+ eye injections because some batches contain glass-like particles. The affected batches (25JAN033A and 25JAN033B) expire in February 2026. No injuries have been reported.

Imprimis NJOF's dexamethasone-moxifloxacin-ketorolac eye injection contains glass-like particles that could contaminate the injection. This medication is used during eye surgery. The affected lots are 25APR001A and 25APR001B, expiring 04/03/2026.

Imprimis NJOF, LLC is recalling specific lots of Dexamethasone Moxifloxacin intraocular injection due to the presence of glass-like particles in the medication. This injection is used during eye surgery. Two affected lots have been identified and distributed nationwide.

Alembic Pharmaceuticals is recalling one lot of Fesoterodine Fumarate 8 mg extended-release tablets because testing found levels of a chemical impurity (diester impurity) that exceed safety limits. The affected lot is 2405003360, which expires January 31, 2026.

Joyful Journeys baby loungers have sides that are too low and openings that are too wide, creating risks that infants could fall out or become trapped. The loungers also lack a stand, making them unsafe on elevated surfaces. These design flaws violate federal safety standards for infant sleep products.