Pennsylvania recalls

Johnson & Johnson is sending updated surgical instructions for HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products used in cataract surgery. The new instructions emphasize that if resistance is felt when inserting the cannula, surgeons should stop, withdraw the cannula, and reassess insertion conditions rather than forcing it—to avoid potential injury to the cornea, iris, or Descemet's membrane (a delicate eye structure).

Medline's blood draw and phlebotomy kits contain antiseptic applicators (BD ChloraPrep Clear and FREPP Clear) with wrinkles in the paper packaging that may compromise the sterile barrier. If the packaging is damaged, the applicators could be exposed to bacterial or microbial contamination before use.

Medline's Ortho Aspiration, Should Block, and Trima Convenience Kits contain sterile applicators with wrinkles in the paper packaging that may compromise the sterile seal. If the sterile barrier is breached, patients could be exposed to microbial contamination, potentially causing localized or serious infection.

Medline Convenience Kits (Eye Kit and Cataract Preop Kit models) contain sterilized applicators with a potential packaging defect—wrinkles in the paper lidding that may compromise the sterile barrier. If the packaging is breached, patients could be exposed to microbial contamination, ranging from no injury to infection.

Medline's C-Section Prep Convenience Kits contain ChloraPrep and FREPP applicators with a potential sterility packaging breach due to wrinkles in the paper lid seal. If the sterile barrier is compromised, users may be exposed to microbial contamination. Health effects could range from no injury to localized infection, or in rare cases, serious infection requiring treatment or hospitalization.

Medline's Labor CDS and Vaginal Delivery Admission Bag kits contain ChloraPrep and FREPP applicators with wrinkled packaging that may compromise the sterile barrier. If the seal is breached, patients and healthcare workers may be exposed to microbial contamination, ranging from no injury to serious infection requiring treatment.

Medline pre-op and cataract surgery kits containing BD ChloraPrep Clear applicators may have compromised sterile packaging due to wrinkles in the paper lidding. If the sterile barrier is breached, patients could be exposed to microbial contamination during surgery.

Medline's blood culture convenience kits contain sterile applicators with a potential packaging defect—wrinkles in the paper lidding may compromise the sterile barrier. If the seal is breached, the applicators could be exposed to microbial contamination, which could potentially cause infection if used.

Medline's IV Start Convenience Kits contain sterile applicators (BD ChloraPrep Clear and FREPP Clear) with wrinkles in the paper packaging that may compromise the sterile barrier. If the seal is breached, patients could be exposed to microbial contamination during IV insertion or blood draws.

Medline's Arterial Line Insertion Kit (Model ART1295) contains sterilization applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the seal is breached, patients could be exposed to microbial contamination, ranging from no effect to serious infection.

Several Medline medical convenience kits—including IV start kits, blood culture kits, and pediatric emergency trays—contain sterile applicators with wrinkles in the packaging that may compromise the sterile barrier. If the packaging is damaged, the contents could be exposed to microbial contamination, which could cause infection ranging from minor to serious.

Medline's Ultrasound Breast Pack (Model DYNJ63375C) contains sterilized applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the packaging is damaged, the applicators could be exposed to microbial contamination before use.

Medline Convenience Kits (Model DYNJ906437D) containing BD ChloraPrep and FREPP applicators have wrinkles in the paper packaging that may compromise the sterile barrier. If the packaging is breached, patients could be exposed to microbial contamination.

Medline's IVS Blood Culture Kits (models DYNDH1920 and DYNDH1920A) contain sterile applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the seal is breached, the applicators could be exposed to microbial contamination before use.

Medline Convenience Kits containing BD ChloraPrep Clear and FREPP Clear applicators may have packaging defects—wrinkles in the paper lid that could compromise the sterile barrier. If the packaging is compromised, the sterile applicators inside could be exposed to microbial contamination before use.

Several Medline Convenience Kits contain BD ChloraPrep Clear and FREPP Clear applicators with wrinkled paper packaging that may compromise the sterile barrier. If the packaging is breached, the applicators could be exposed to microbial contamination, which could lead to localized or serious infection in patients.

Two Medline Convenience Kits contain BD ChloraPrep Clear applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the sterile seal is breached, the applicators could be contaminated with microbes, potentially exposing patients and users to infection.

Diagnostica Stago identified a positive drift in quality control (QC) values in one lot of STA Staclot Protein S reagent within the product's stated 4-hour stability period. This drift could affect the accuracy of test results performed during that window. The issue affects reagent Lot 273074 distributed nationwide.

Halyard medical convenience kits contain Ritmed Neurological Sponges that may have unexpected variability in endotoxin levels. Endotoxins are bacterial substances that can trigger immune reactions in patients. The affected kits were distributed nationwide to surgical facilities.

AVID Medical is recalling 70 different neurological and spine surgical kits that contain Ritmed Neurological Sponges. The sponges may have unexpected variability in endotoxin levels, which could affect their safety and sterility during surgical use.

Halyard medical convenience kits contain Ritmed Neurological Sponges that may have unexpected variability in endotoxin levels. Endotoxins are bacterial substances that could trigger an immune response if present at higher-than-expected levels. About 11,763 kits across multiple surgical specialties are affected.

Philips has identified an unintended radiation issue affecting Philips Brilliance CT 64 CT scanner systems (Software 4.1.10.x) that could impact equipment performance. The issue affects multiple Philips CT system models including IQon, iCT, Ingenuity, and Brilliance CT 64.

Philips has identified an unintended radiation issue affecting Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could impact equipment performance. The issue affects specific software versions and product codes distributed in the US and US territories.

Philips has identified an unintended radiation issue affecting the IQon Spectral CT and related CT systems (iCT, Ingenuity, and Brilliance CT 64 models). This issue could affect the performance of the equipment. The problem was found in software version 4.7.7.x.

Philips has identified an unintended radiation issue affecting Philips Brilliance iCT, Brilliance iCT Upgrades, and Brilliance iCT SP CT scanner systems running software version 4.1.10.x. This issue could affect the performance and safety of the equipment.

Wonton Specialist Inc. cooked noodles (16 oz and 5 lb bags) contain FD&C Red No. 40, a food dye that is not declared on the label. The product was distributed in New York, New Jersey, and Pennsylvania. No injuries have been reported.

Wonton Specialist Inc. dumpling skin (16 oz packages) contains FD&C Red No. 40 food dye that is not listed on the label. The product was distributed in New York, New Jersey, and Pennsylvania. About 240 bags are affected.

Wonton Specialist Inc. wonton skins (16 oz packages) contain FD&C Red No. 40, a food dye that was not declared on the label. This poses a risk to people with allergies or sensitivities to this dye. About 480 bags were distributed in New York, New Jersey, and Pennsylvania.

Wonton Specialist Inc. is recalling 16 oz packages of Lo Mein Noodle because they contain FD&C Red No. 40 (a food dye) that is not listed on the label. This can be a concern for people with allergies or sensitivities to this ingredient or those who avoid it for dietary or religious reasons.

Wonton Specialist Inc. noodles (12 oz and 5 lb packages) contain FD&C Red No. 40 food dye that is not listed on the label. This undeclared ingredient may pose a risk to people with allergies or sensitivities to the dye. About 550 bags are affected.