The Recall Desk

Archive

September 2025 recalls

525 recalls were announced in September 2025.

What the numbers show

Critical
68
Severe
54
High
234
Moderate
98
Low
71

Of the 525 recalls this month scored against our rubric, 13% are Critical, 10% are Severe.

Which agencies issued them

301–400 of 525

  • HighFDA (Devices)·Z-2524-2025·2025-09-10

    CADD yellow 100 mL reservoirs recalled over weakened medication bag welds

    Smiths Medical CADD Yellow Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7300-24, may have weakened medication bag welds that could allow leakage. 289,098 units are affected.

    Product
    Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·25V589000·2025-09-10

    Volvo Recalls 2026 Models Due to Damaged Front Seat Belt Retractors

    Volvo is recalling 2026 V60, V90, XC60, and XC90 models because damaged seat belt retractors may fail to restrain occupants in a crash.

    Product
    VOLVO — VOLVO V60CCMHEV, V90CCMHEV, XC60MHEV, redundant XC90MHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2512-2025·2025-09-10

    CVS honey wound pads recalled over packaging failures breaching sterile barrier

    CVS Honey Pads, catalog numbers 9370613 and 937404, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 111,492 units are affected.

    Product
    Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2025·2025-09-10

    Spinal decompression implants recalled after review found instrument and device breakage

    Superion Indirect Decompression System implants and kits are recalled because a product performance review found the device and instruments are not consistently meeting expected performance, including breakage. 70,516 units are affected.

    Product
    Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2025·2025-09-10

    Sterile cover kits recalled because elastic bands may detach during surgery

    Sterile Cover 10-Pack Shipper Box Assemblies are recalled because elastic bands in the kit may detach or fracture during surgery, risking retained foreign bodies and surgical site infection. 200 units are affected.

    Product
    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2025·2025-09-10

    External fixation universal joints recalled because pins may become dislodged

    Medshape Universal Joints, REF DNE-9000-UJ, are recalled because a pin in the bone external fixation system can become dislodged, causing frame instability. 849 units are affected.

    Product
    Medshape Universal Joints, REF: DNE-9000-UJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2025·2025-09-10

    Tumor profiling assay recalled after incorrect result gave wrong therapy recommendation

    One MI Cancer Seek tumor mutational profiling assay is recalled because an incorrect test result was provided that indicated the incorrect drug therapy recommendation.

    Product
    MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2025·2025-09-10

    NRFit yellow cassette reservoirs recalled over weakened medication bag welds

    Smiths Medical NRFit CADD Yellow Medication Cassette Reservoirs, 100 mL, product code 21-7600-24, may have weakened medication bag welds that could allow leakage. 15,546 units are affected.

    Product
    Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2506-2025·2025-09-10

    MediHoney paste tubes recalled over packaging failures breaching the sterile barrier

    MediHoney Paste tubes, catalog numbers 31515 and 31535, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 141,620 units are affected.

    Product
    Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0550-2025·2025-09-10

    HEB blueberry flavored yogurt pretzels recalled over undeclared wheat allergen

    HEB 8 oz Blueberry Flavored Yogurt Pretzels, lots 080226 and 080326, are recalled for an undeclared wheat allergen. The recall covers 468 cases of 12 packages each, distributed in Texas.

    Product
    Product Name: Blueberry Pretzels " Brand Name: HEB " Description: 8oz HEB Blueberry Flavored Yogurt Pretzels " UPC Codes: 9787011400 " Lot Numbers: 080226, 080326 " Best By / Use By Dates: 080226 & 080326 " Package Size: 8oz " Establishment Number: 008046575
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2520-2025·2025-09-10

    Surgical drape packs recalled because open seals may compromise sterility

    Orthopedic Pack model 88041-12 and Universal Pack model 77165-06 are recalled because the surgical drape packs may have open seals that could compromise sterility. 1,316 units are affected.

    Product
    Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-09102025-01·2025-09-10

    Raw sirloin beef tips recalled due to misbranding and undeclared allergens

    The USDA FSIS issued a public health alert for Bianco & Sons raw sirloin beef tips because the product labels failed to declare common allergens—specifically sesame and wheat—posing risks to consumers with those allergies.

    Product
    Bianco Inc. — FSIS Issues Public Health Alert for Raw Sirloin Beef Tip Product Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0554-2025·2025-09-10

    Golden raisins recalled because sulfites are undeclared on the package

    Nirwana Foods Golden Raisins, 28 oz clear bags, lot 24/351-2410, are recalled because sulfites are undeclared. The product was distributed in New Jersey and New York.

    Product
    Nirwana Foods, Golden Raisin, 28 oz (794g), Net Wt. 1.75 LBS, Clear Bags, 20 bags Per Case, keep at room Temperature
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2508-2025·2025-09-10

    MediHoney hydrogel sheet dressings recalled over packaging failures compromising sterility

    MediHoney Adhesive Hydrogel Sheet Dressings, catalog numbers 31720 and 31740, are recalled after packaging failures were identified that could breach the sterile barrier. 994 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2025·2025-09-10

    Interventional imaging systems recalled because single phase UPS may fail on power loss

    Philips Allura systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,006 units are affected.

    Product
    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2505-2025·2025-09-10

    MediHoney paste tubes 31505 recalled over packaging failures affecting sterility

    MediHoney Paste, catalog number 31505, is recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 15,441 units are affected.

    Product
    Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2025·2025-09-10

    Radiotherapy systems recalled over software allowing more than two daily fractions

    RefleXion X1 systems are recalled because an incorrect software configuration potentially allows more than two treatment fractions within a 12-hour period, which could lead to toxicity. 11 units are affected.

    Product
    RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0614-2025·2025-09-10

    KIMMTRAK injection recalled after testing subpotent in three affected lots

    KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, is recalled nationwide as a subpotent drug. 7,572 vials are affected.

    Product
    KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2507-2025·2025-09-10

    MediHoney HCS sheet dressings recalled over packaging failures breaching sterility

    MediHoney HCS Sheet Dressings, catalog numbers 31612, 31622 and 31644, are recalled after packaging failures were identified that could breach the sterile barrier. 3,583 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2509-2025·2025-09-10

    MediHoney non-adhesive hydrogel dressings recalled over sterile barrier packaging failures

    MediHoney Non-Adhesive Hydrogel Sheet Dressings, catalog numbers 31620 and 31640, are recalled after packaging failures were identified that could breach the sterile barrier. 5,374 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2511-2025·2025-09-10

    MediHoney surgical adhesive sheets recalled over sterile barrier packaging failures

    MediHoney HCS Surgical Adhesive Sheet dressings, catalog number 31738, lot 53824, are recalled after packaging failures were identified that could breach the sterile barrier. 4 units are affected.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0551-2025·2025-09-10

    Breaded butterfly shrimp recalled over possible contamination with cesium-137

    Panko Style Breaded Butterfly Shrimp in 12 lb master cartons, product of Indonesia, is recalled because the product may be contaminated with Cesium-137. 776 cases are affected.

    Product
    Panko Style Breaded Butterfly Shrimp (16/20 CT per pound) in bulk packaging, corrugated master cartons. Master carton case is NET WT 12 lbs. (192 OZ) 5.44 kg (4 x 3lbs cartons), Farm Raised Clean Tail. Product of Indonesia, KEEP FROZEN, Item# 1SH0318505G
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·H-0562-2025·2025-09-10

    Chocolate pecan fudge recalled because pecan and egg are undeclared

    Chocolate Pecan Fudge from The Candy Barn is recalled because the specific tree nut pecan and egg are not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    Chocolate Pecan Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0552-2025·2025-09-10

    Cleantail breaded butterfly shrimp recalled over possible cesium-137 contamination

    Admiral of the Fleet and Portico Seafood Classic cleantail breaded butterfly shrimp in bulk master cartons is recalled because it may be contaminated with Cesium-137. 1,200 cases are affected.

    Product
    ADMIRAL OF THE FLEET and PORTICO SEAFOOD CLASSIC (SYSCO) Cleantail Breaded Butterfly Shrimp (16/20 CT per pound) in bulk packaging, corrugated master cartons. Master carton case is NET WT 12 lbs. (192 OZ) 5.44 kg (4 x 3lbs cartons), and carton case (4 x 3lb (1.36 kg), KEEP…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2496-2025·2025-09-10

    InPen app recalled over software errors affecting insulin dose reminders

    Medtronic is recalling the InPen App for iOS and Android because software design errors could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. 6,816 units are affected.

    Product
    InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0565-2025·2025-09-10

    English toffee recalled because pecans are missing from the contains statement

    English Toffee from The Candy Barn is recalled because the specific tree nut pecans is not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    English Toffee, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 5oz, packed in flexible plastic bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0606-2025·2025-09-10

    Compounded semaglutide 2 mL vials recalled after testing subpotent

    Semaglutide 2.5 mg/mL injection, 2 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 642 vials are affected.

    Product
    Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0619-2025·2025-09-10

    Chlorpromazine 200 mg tablets recalled over micro-organism on packaging component

    Amneal chlorpromazine hydrochloride tablets, 200 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2514-2025·2025-09-10

    Dental titanium bases recalled because the post is oriented 180 degrees off

    NobelBiocare Tri-Lobe-compatible WP 6.0mm engaging titanium bases, lot 277097, are recalled because the base was manufactured 180 degrees around the post from the correct position. 11 units are affected.

    Product
    NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0616-2025·2025-09-10

    Chlorpromazine 25 mg tablets recalled after micro-organism found on packaging coil

    Amneal chlorpromazine hydrochloride tablets, 25 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2501-2025·2025-09-10

    Uric acid monitoring kits recalled over missing premarket clearance or approval

    A second lot group of Blood Uric Acid Monitoring System kits, model eB-U01, covering all lots made up to June 20, 2022, is recalled for distribution without premarket clearance. 2,580 units are affected.

    Product
    Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2025·2025-09-10

    Defibrillator recalled because required post-service inspections were not performed

    One LIFEPAK CR2 defibrillator is recalled because required inspections were not performed on units that had gone through servicing.

    Product
    LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2518-2025·2025-09-10

    Hemodynamic recording systems recalled over pressure sensor error during blood pressure measurement

    Merge Hemo systems are recalled because certain Schiller ARGUS PB-3000 patient data modules trigger a Pressure Sensor Defective error during non-invasive blood pressure measurement above 240 mmHg. 84 units are affected.

    Product
    Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2492-2025·2025-09-10

    RayStation 11B software recalled over non-unique DICOM instance identifiers

    RayStation 11B and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2490-2025·2025-09-10

    RayStation 10B planning software recalled over DICOM identifiers not guaranteed unique

    RayStation 10B and 10B Service Pack 1 radiation therapy treatment planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2491-2025·2025-09-10

    RayStation 11A planning software recalled over non-unique DICOM instance identifiers

    RayStation 11A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2498-2025·2025-09-10

    LIFEPAK 1000 defibrillators recalled over inspections missed after unit servicing

    Three LIFEPAK 1000 defibrillators are recalled because required inspections were not performed on units that had gone through servicing.

    Product
    LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2504-2025·2025-09-10

    Fluoroscopic X-ray systems recalled over air baffle missing from internal PCs

    Philips Allura Xper interventional fluoroscopic X-ray systems are recalled because an air baffle component may be missing in some Nehalem FlexVision-2 PCs. 192 units are affected.

    Product
    Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2495-2025·2025-09-10

    RayStation 2023B and 2024A software recalled over non-unique DICOM identifiers

    RayStation 2023B, 2024A and 2024A SP3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2497-2025·2025-09-10

    LIFEPAK 15 defibrillators recalled because post-service inspections were not performed

    Four LIFEPAK 15 defibrillators are recalled because required inspections were not performed on units that had gone through servicing.

    Product
    LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2025·2025-09-10

    Chlorpromazine 50 mg tablets recalled over micro-organism on packaging coil

    Amneal chlorpromazine hydrochloride tablets, 50 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2493-2025·2025-09-10

    RayStation 12A planning software recalled over duplicate DICOM instance identifier risk

    RayStation 12A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2025·2025-09-10

    RayStation 7 and 8A software recalled over DICOM instance identifier defect

    RayStation 7, 8A and 8A Service Pack 1 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2488-2025·2025-09-10

    RayStation 8B and 9A software recalled over DICOM identifier uniqueness defect

    RayStation 8B, its service packs and 9A radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0615-2025·2025-09-10

    Sulfamethoxazole and trimethoprim tablets recalled over micro-organism on packaging coil

    Amneal sulfamethoxazole and trimethoprim double strength tablets are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0618-2025·2025-09-10

    Chlorpromazine 100 mg tablets recalled over micro-organism on packaging coil

    Amneal chlorpromazine hydrochloride tablets, 100 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2516-2025·2025-09-10

    Spinal implant inserters recalled over potential missing pins at the tip

    TOPS Inserters, model 82889, part of the TOPS System Instrument Set, are recalled because of the potential for missing pins at the tip of the inserter. 30 units are affected.

    Product
    TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2500-2025·2025-09-10

    Uric acid meter kits recalled for distribution without premarket clearance

    Blood Uric Acid Monitoring System kits, model eB-U01, are recalled because the products were distributed without premarket clearance or approvals. 2,240 units are affected.

    Product
    Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2489-2025·2025-09-10

    RayStation 9B and 10A software recalled over non-unique DICOM identifiers

    RayStation 9B, 9B SP1, 10A and 10A service pack radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2494-2025·2025-09-10

    RayStation 6 service packs recalled over DICOM identifier uniqueness defect

    RayStation 6 Service Packs 1, 2 and 3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.

    Product
    RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2517-2025·2025-09-10

    Flowmeter patches recalled over expiry date printed one year too early

    FloPatch FP120 flowmeter patches, lot 03250602, are recalled because the human readable expiry date on the outer shipping packaging reads 2025-06-20 when it should read 2026-06-20. 9 units are affected.

    Product
    FloPatch FP120, REF: FP120-FOT01-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V588000·2025-09-09

    Storyteller Overland Recalls GXV Hilt Vehicles for Wiring Fire Risk

    Storyteller Overland is recalling 2024-2026 GXV Hilt recreational vehicles because auxiliary power system wires may be damaged, increasing the risk of a fire.

    Product
    STORYTELLER OVERLAND — STORYTELLER OVERLAND GXV HILT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V586000·2025-09-09

    Alfa Romeo Giulia and Stelvio Recalled for Fuel Pump Failure Risk

    Chrysler is recalling 2017-2019 Alfa Romeo Giulia and 2018-2019 Stelvio vehicles because a failing fuel pump may cause loss of drive power, increasing crash risk.

    Product
    ALFA ROMEO — ALFA ROMEO GIULIA, STELVIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V587000·2025-09-09

    Zero Motorcycles Recalls 2023-2024 Models Due to Wiring Defect

    Zero Motorcycles is recalling 2023-2024 DSR, DSR/X, DS, and DSRP models because improperly routed wires may break, causing a loss of drive power and increasing crash risk.

    Product
    ZERO — ZERO DS, DSR, DSR/X, DSRP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V585000·2025-09-08

    2025 Rivian R1S and R1T Recalled Due to Software Defect

    Rivian is recalling certain 2025 R1S and R1T vehicles because the Hands-Free Highway Assist software may fail to detect lead vehicles, increasing crash risk. A free over-the-air software update is available.

    Product
    RIVIAN — RIVIAN R1S, R1T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V584000·2025-09-06

    Spartan Fire Recalls Fire Trucks Due to Door Latch Defect

    Spartan Fire is recalling specific 2023-2026 fire trucks because a door latch defect may prevent the cab door from opening, potentially trapping occupants.

    Product
    SPARTAN FIRE — SPARTAN FIRE, KME METROSTAR, redundant PREDATOR, PREDATOR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V583000·2025-09-05

    Honda CRF1100 Africa Twin Motorcycles Handlebar Switch Corrosion

    Honda is recalling certain 2020–2025 CRF1100 Africa Twin motorcycles due to corrosion of the left handlebar switch harness, which may disable the horn or headlight beam-switching function. This electrical failure increases crash and injury risk.

    Product
    HONDA — HONDA CRF1100
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V582000·2025-09-05

    2025 Acura RDX Electric Power Steering Software Calibration Defect

    Honda is recalling certain 2025 Acura RDX vehicles because the electric power steering software may not be properly calibrated, which can cause loss of power steering assist and increase crash risk.

    Product
    ACURA — ACURA RDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V575000·2025-09-04

    2025 Jeep Wagoneer S Recalled for Incorrect Cross Beam

    Chrysler is recalling certain 2025 Jeep Wagoneer S vehicles with an incorrect cross car beam in the instrument panel. The defect may not adequately protect occupants in a crash.

    Product
    JEEP — JEEP WAGONEER S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V574000·2025-09-04

    2025 Jeep Wagoneer S Incorrectly Installed Spring Disables Park Function

    Chrysler recalls 2024-2025 Jeep Wagoneer S and Dodge Charger electric vehicles due to an incorrectly installed spring that may disable the park function, potentially causing vehicle rollaway.

    Product
    DODGE — DODGE, JEEP CHARGER EV, WAGONEER S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25455·2025-09-04

    Cordless grease guns recalled after hose failures caused five laceration injuries

    About 62,927 Makita professional cordless grease guns and grease gun hoses are recalled because the flexible hose can develop a hole and eject grease. Five hose failures with laceration injuries were reported.

    Product
    Makita Professional Cordless Grease Guns and Makita Grease Gun Hoses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V577000·2025-09-04

    2023–2025 Toyota BZ4X, Lexus RZ, and Subaru Solterra HVAC Defroster System Recall

    Toyota is recalling certain 2023–2025 BZ4X, Lexus RZ, and Subaru Solterra vehicles because the defroster and defogger system may become inoperative due to electrical compressor failure, decreasing driver visibility and increasing crash risk.

    Product
    LEXUS — LEXUS, TOYOTA, SUBARU RZ, BZ4X, SOLTERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V578000·2025-09-04

    Jayco Recalls 2026 Seismic Fifth Wheels for Incorrect Weight Labels

    Jayco is recalling 2026 Seismic fifth wheel travel trailers because the certification label lists an incorrect Gross Axle Weight Rating (GAWR).

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL SEISMIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25458·2025-09-04

    Firearm chamber locks recalled because they can be forcibly removed

    About 300 AR-15 Chamber Lock Pro firearm locks shipped between June 2 and July 15, 2025 are recalled because a manufacturing defect allows them to be forcibly removed, permitting access to the firearm.

    Product
    AR-15 Chamber Lock Pro Firearm Locks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V573000·2025-09-04

    2025 Chrysler Pacifica side curtain air bags recalled for inadequate pressure retention

    Chrysler is recalling certain 2025 Pacifica and Voyager vehicles due to defective side curtain air bags. The air bags may have insufficient pressure retention from improperly sealed seams, increasing the risk of ejection during a crash.

    Product
    CHRYSLER — CHRYSLER PACIFICA, VOYAGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V580000·2025-09-04

    IC Bus School Buses Recalled for Structural Reinforcement Defect

    International Motors is recalling certain 2016-2026 IC Bus CESB and 2016-2021 RESB school buses due to missing or incomplete underfloor reinforcement that may compromise crash safety. Owners should contact a dealer for free inspection and installation.

    Product
    IC BUS — IC BUS CESB, RESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0528-2025·2025-09-03

    Grass-fed pepper jack cheese recalled over potential Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op and Copia Collective 100% Grass-Fed Pepper Jack Cheese, lot 251661, is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I.

    Product
    1) Middlefield Original Cheese Co-op 100% Grass-Fed Pepper Jack Cheese, 8 oz. individual units, 5 lb. loaves, and 40 lb. loaves, packaged in plastic with lot code 251661 2) Copia Collective 100% Grass-Fed Pepper Jack Cheese, 8 oz. individual units, packaged in plastic with lot…
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·H-0538-2025·2025-09-03

    Freeze dried organic mango powder recalled over potential Salmonella contamination

    Organic Mango Freeze Dried Powder in 15-kilogram bulk boxes is recalled for potential Salmonella contamination. The FDA classified the action as Class I, its most serious category.

    Product
    Organic Mango Freeze Dried Powder, Bulk, 15-kilogram boxes (2 packs of 7.5 kilograms in a carton box), 7.5kg packaged in multi-wall kraft paper boxes with inner food-grade polyethylene liner, Store in a cool, dry place away from direct sunlight; keep sealed until use
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2343-2025·2025-09-03

    Insulin pumps recalled over malfunction that stops insulin delivery and alerts

    Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.

    Product
    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2460-2025·2025-09-03

    Reprocessed electrophysiology catheters recalled over small residual particulates in specific lots

    Medline ReNewal reprocessed St. Jude Medical diagnostic electrophysiology catheters are recalled because specific lots may contain small residual particulates. The FDA classified the action as Class I.

    Product
    Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0529-2025·2025-09-03

    Horseradish flavored cheese recalled over potential Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op Horseradish Flavored Cheese, 8 oz, lot 2524061, is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I.

    Product
    Middlefield Original Cheese Co-op Horseradish Flavored Cheese, 8 oz. individual units, packaged in plastic with lot code 2524061
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·H-0530-2025·2025-09-03

    Monterey jack and farmers cheese recalled for possible Listeria monocytogenes contamination

    Middlefield Original Cheese Co-op Monterey Jack and Farmers Cheese are recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I. 640 pounds are affected.

    Product
    1) Middlefield Original Cheese Co-op Monterey Jack Cheese, 8 oz. individual units, 5 lb. loaves, and 40 lb. blocks, packaged in plastic 2) Middlefield Original Cheese Co-op Farmers Cheese, 8 oz. individual units, 5 lb. loaves, and 40 lb. blocks, packaged in plastic
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·H-0527-2025·2025-09-03

    Paneer cheese recalled over potential Listeria monocytogenes contamination in foodservice bags

    Paneer Cheese in 5 lb vacuum-sealed bags, lot 2517061, distributed for foodservice, is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I.

    Product
    Paneer Cheese, Net Wt. 30 lbs., packaged in 5 lb. vacuum-sealed plastic bags with lot code 2517061, packed 6 bags per white cardboard case with packed on date 6-18-25, distributed for food service only
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2423-2025·2025-09-03

    Limb salvage canal filling stems recalled after unidentified substance found on devices

    ELEOS Bowed Canal Filling Stems are recalled because an unidentified substance of unknown impact was found on devices during a retrospective evaluation. 30 units are affected.

    Product
    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V572000·2025-09-03

    Ford Recalls Vehicles Due to Rearview Camera Display Issues

    Ford is recalling specific 2015-2019 vehicles because the rearview camera may display a distorted, inverted, or blank image, increasing crash risk.

    Product
    FORD — FORD, LINCOLN MUSTANG, EDGE, F-550 SD, EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2025·2025-09-03

    Custom loupes with Phantom frames recalled over nickel nose pad allergy risk

    Orascoptic custom loupes configured with Phantom frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 10,611 units are affected.

    Product
    Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0603-2025·2025-09-03

    H-E-B alcohol pads recalled for isopropyl alcohol below labeled concentration

    H-E-B inControl Sterile Alcohol Pads, 100 per container, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 300,000 pads.

    Product
    INCONTROL ALCOHOL — INCONTROL ALCOHOL (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2025·2025-09-03

    Hip and knee procedure packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems anterior hip, total knee and hip prosthesis packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 588 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2468-2025·2025-09-03

    Craniotomy and shunt packs recalled over unjustified sterilization of certain components

    American Contract Systems craniotomy and shunt procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 204 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0605-2025·2025-09-03

    Alcohol prep pads recalled for isopropyl alcohol below labeled concentration

    Rite Aid Pharmacy first aid alcohol prep pads are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 984,000 pads.

    Product
    ALCOHOL — ALCOHOL (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2025·2025-09-03

    Loupe nose pad kits recalled because nickel content may cause allergic reaction

    Orascoptic Dragonfly Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 743 kits are affected.

    Product
    Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0604-2025·2025-09-03

    Good Neighbor alcohol prep pads recalled for alcohol below labeled concentration

    Good Neighbor Pharmacy Alcohol Prep Pads, distributed by AmerisourceBergen, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. 66,000 pads are affected.

    Product
    GOOD NEIGHBOR PHARMACY ALCOHOL ANTISEPTIC SKIN CLEANSER — GOOD NEIGHBOR PHARMACY ALCOHOL ANTISEPTIC SKIN CLEANSER (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2420-2025·2025-09-03

    Operating tables recalled because interference can leave them unresponsive to controls

    Corin Operating Tables are recalled because interference, such as from high-frequency surgical equipment used at the same time, can leave the table unresponsive to both the remote control and the override panel.

    Product
    Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0577-2025·2025-09-03

    Hostess Ding Dongs recalled over mold traced to malfunctioning cooler

    Hostess Ding Dongs in twin packs and 10- and 16-count cartons are recalled for mold, which the firm traced to a malfunctioning cooler after customer complaints rose. 60,630 cases are affected.

    Product
    Hostess Ding Dongs CHOCOLATE CAKE WITH CREAMY FILLING 2.55 oz twin pack UPC 8 88109 01002 7; 10-1.28 oz carton (12.7 oz) UPC 8 88109 11061 1; 16-1.28 oz carton (20.31 oz) Individual selling unit - UPC 8 88109 01182 6 16-count selling unit - UPC 8 88109 11092 5
    Category
    Food
    Distribution
    42 states
  • HighFDA (Devices)·Z-2467-2025·2025-09-03

    Perfusion and laparoscopy packs recalled over unjustified sterilization of certain components

    American Contract Systems supplement, kidney perfusion and lapchol/appy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 6,617 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2342-2025·2025-09-03

    C-arm imaging systems recalled over missing lead tape in collimator covers

    GE HealthCare OEC 9800 and OEC 9900 Elite C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.

    Product
    GE HealthCare OEC 9900 Elite C-arm Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2025·2025-09-03

    Cystoscopy and TUR packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems cysto and TUR basin packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,127 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number…
    Category
    Medical Device
    Distribution
    2 states

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