The Recall Desk

Archive

September 2026 recalls

593 recalls were announced in September 2026.

What the numbers show

Critical
44
Severe
191
High
245
Moderate
106
Low
7

Of the 593 recalls this month scored against our rubric, 7% are Critical, 32% are Severe.

201–300 of 593

  • HighFDA (Devices)·Z-3176-2026·2026-09-23

    Happiest Baby SNOO Sleep Sacks Recalled for Lack of FDA Review

    Happiest Baby, Inc. is recalling SNOO Sleep Sacks because they have not been reviewed for safety and effectiveness by the FDA.

    Product
    Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534 S2101-535 S2101-536 S2101-541 S2101-551 S2102-508-10 S2102-508-9 S2103-501…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3193-2026·2026-09-23

    Mirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure

    Mirion Technologies is recalling 783 Captus 4000e Thyroid Uptake Systems because a tension bolt may fail, causing the spring arm to fall unexpectedly.

    Product
    Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3212-2026·2026-09-23

    ICU Medical Recalls CADD Yellow Medication Cassette Reservoirs Due to Leakage

    ICU Medical is recalling 185,688 CADD Yellow Medication Cassette Reservoirs because they may leak medication at the connector joint, potentially interrupting therapy or causing exposure to harmful agents.

    Product
    CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3179-2026·2026-09-23

    Embecta Medical Recalls Nano Pro Pen Needles Distributed as Commercial Devices

    Embecta Medical II LLC is recalling Nano Pro Un-Cannulated Demo Samples because investigational-use-only pen needles were inadvertently distributed as commercially marketed devices.

    Product
    EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3189-2026·2026-09-23

    Datex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect

    Datex-Ohmeda is recalling Aisys anesthesia systems because electronic gas mixer assemblies may fail, interrupting anesthetic delivery and requiring clinician intervention.

    Product
    Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3147-2026·2026-09-23

    Bayer Medical Care Recalls Stellant FLEX Syringe Kits Due to Sterilization Issues

    Bayer Medical Care is recalling 27,800 Stellant FLEX Syringe Kits because some may not have been properly sterilized due to a manufacturing issue.

    Product
    MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3167-2026·2026-09-23

    GE Healthcare Enterprise Archive V8 Software Recalled for Data Association Errors

    GE Healthcare is recalling Enterprise Archive V8 software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis.

    Product
    Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1386-2026·2026-09-23

    Best Friends Bakery Recalls Pumpkin Spice No Bake Cookies for Allergen Mislabeling

    Best Friends Bakery is recalling 1,416 units of Pumpkin Spice No Bake Cookies due to peanut and egg labeling errors.

    Product
    PUMPKIN SPICE NO BAKE COOKIE NET WT 3.5 oz. INGREDIENTS: WHOLE GRAIN OATS, MILK, MARGARINE***WATER, SALT, CONTAINS LESS THAN 2% OF THE FOLLOWING: SOY LECITHIN, VEGETABLE MONO & DIGLYCERIDES, POTASSIUM SORBATE***, CITRIC ACID, NATURAL & ARTIFICIAL FLAVOR, BETA CAROTENE, VITAMIN A…
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-3182-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3142-2026·2026-09-23

    Philips PIC iX Essentials Patient Information System Software Recall

    Philips North America is recalling 312 units of the PIC iX Essentials patient information system due to a software malfunction that may cause the system to freeze.

    Product
    Philips PIC iX Essentials REF:867093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3197-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components manufactured with aged polyethylene material that may oxidize and increase wear.

    Product
    ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3169-2026·2026-09-23

    GE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error

    GE Healthcare is recalling 116 Centricity PACS Server V7 systems because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.

    Product
    Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3185-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3202-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implant Components Due to Material Aging

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made from aged polyethylene. The material may oxidize and wear excessively, potentially causing device failure.

    Product
    BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3168-2026·2026-09-23

    GE Healthcare Recalls Centricity PACS Software Due to Data Association Errors

    GE Healthcare is recalling Centricity PACS software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.

    Product
    Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3166-2026·2026-09-23

    GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors

    GE Healthcare is recalling Centricity Enterprise Archive software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.

    Product
    Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3205-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Polyethylene Material Aging

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components because aged polyethylene material may cause increased wear and device failure.

    Product
    SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3141-2026·2026-09-23

    Philips Patient Information Center iX Software Malfunction Recall

    Philips North America is recalling 7,359 Patient Information Center iX units due to a software malfunction that may cause the system to freeze and become unresponsive.

    Product
    Philips Patient Information Center iX REF:866389
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3145-2026·2026-09-23

    Maquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues

    Maquet is recalling Percutaneous Insertion Kits because the packaging may not consistently maintain sterile barrier integrity.

    Product
    Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3178-2026·2026-09-23

    restor3d Recalls Kinos Axiom Total Ankle Systems with Incorrect Cutting Guides

    restor3d Inc. is recalling two Kinos Axiom Total Ankle Systems because they were packaged with incorrect patient-specific cutting guides, which may lead to surgical complications.

    Product
    Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3209-2026·2026-09-23

    Medline Myringotomy Kits Recalled for Potential Sterility Compromise

    Medline Industries is recalling 60 Myringotomy Pack-LF kits due to open seals that may compromise sterility and lead to patient infection.

    Product
    Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1382-2026·2026-09-23

    Buckhead Tuna Recalled for High Scombrotoxin Levels

    Buckhead Meat Company is recalling specific lots of tuna due to high levels of scombrotoxin detected by the NJ Department of Health.

    Product
    Buckhead, Tuna, 10lb cs, 12lb cs, 15lb cs, 3-5lb cs , Styrofoam container, Keep Refrigerated
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-3199-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made with aged UHMWPE material. The material may oxidize, leading to increased wear, device fracture, or the need for revision surgery.

    Product
    ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3203-2026·2026-09-23

    Howmedica Recalls Scorpio Receded Metal Backed Patella Implants

    Howmedica Osteonics Corp. is recalling specific Scorpio knee implant components due to aged polyethylene material that may cause increased wear and potential device failure.

    Product
    SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3165-2026·2026-09-23

    NOxBOXi Nitric Oxide Delivery System Recalled for Tubing Leak Risk

    NOXBOX LTD is recalling 1,547 NOxBOXi Nitric Oxide Delivery Systems due to potential oxygen tubing leaks that may cause oxygen desaturation.

    Product
    NOxBOXi Nitric Oxide Delivery System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3187-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocars Due to Cracking Risk

    Stryker is recalling 9,072 XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3186-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1343-2026·2026-09-23

    Mercer's Ice Cream Sandwiches Recalled for Undeclared Peanuts

    Quality Dairy Farms Inc. is recalling Mercer's brand ice cream sandwiches in New York due to undeclared peanuts.

    Product
    Mercer's brand 6 ICE CREAM SANDWICHES TO GO; packaged in clear plastic; ice cream sandwiches may be rolled in peanuts which are visible through product packaging Ingredients: Cream, sugar, nonfat milk, whey, cocoa (alkalized), stabilizer (guar gum, carrageenan), chocolate wafer…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-3144-2026·2026-09-23

    Maquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues

    Maquet Cardiopulmonary GmbH is recalling Percutaneous Insertion Kits because packaging may not consistently maintain sterile barrier integrity.

    Product
    Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3183-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3190-2026·2026-09-23

    Datex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect

    Datex-Ohmeda is recalling 140 Aisys CS2 anesthesia systems because electronic gas mixer assemblies may fail, interrupting anesthetic delivery and requiring clinician intervention.

    Product
    Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3181-2026·2026-09-23

    Blood Culture Kits Recalled Due to Potential Sterile Barrier Compromise

    Medical Action Industries is recalling blood culture kits containing BD ChloraPrep applicators with potentially compromised sterile seals, posing a risk of localized skin infection.

    Product
    Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3191-2026·2026-09-23

    Datex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect

    Datex-Ohmeda is recalling seven Aisys CS2 anesthesia systems because a gas mixer defect can interrupt anesthetic delivery, requiring clinician intervention to prevent decreased patient effect.

    Product
    Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3210-2026·2026-09-23

    Medline Recalls Cataract Convenience Kits Due to Open Sterile Seals

    Medline Industries is recalling 336 cataract convenience kits because open sterile seals may compromise sterility and lead to patient infection.

    Product
    Convenience kits CATARACT PACK DYNJ59881A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V609000·2026-09-23

    Forest River Recalls 2026-2027 Dynamax Isata RVs Due to Ladder Defect

    Forest River is recalling 2026-2027 Dynamax Isata recreational vehicles because the bunk ladder may loosen if attached to a wooden mattress insert, increasing injury risk.

    Product
    DYNAMAX — DYNAMAX ISATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3184-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocars Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1384-2026·2026-09-23

    Elegant Foods Golden Raisins Recalled for Undeclared Sulfites

    Elegant Foods, LLC is voluntarily recalling 5-pound bags of Golden Raisins in Wisconsin due to undeclared sulfites.

    Product
    Elegant Foods Golden Raisins, 5 pound. 537 Atlas Ave, Madison, WI 53714.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-1387-2026·2026-09-23

    Tiffany Food Corp Recalls Hexing Haw Balls Candy Due to Unapproved Dye

    Tiffany Food Corp is recalling Hexing Haw Balls candy because it contains the unapproved dye Ponceau 4R.

    Product
    Hexing Haw Balls candy; packaged in 200g/0.44 lb./7.05 oz clear plastic bag; Ingredients: haw, white sugar, water.; Serving suggestion: ready to eat. Storage: keep in cool and dry place and keep tightly closed in refrigerator after opening.; PRODUCT OF CHINA; UPC 6 920603 810025
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-0845-2026·2026-09-23

    Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

    Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product was distributed nationwide.

    Product
    Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3211-2026·2026-09-23

    Reign Medical Clench Staple System Recalled for Unestablished Performance

    F & A Foundation is recalling 600 units of Reign Medical Clench Staple Systems because the device's performance characteristics have not been adequately established.

    Product
    Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-40907; 11mm x 10mm/152-41110; 15mm x 12mm/152-41512; 18mm x…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1385-2026·2026-09-23

    Elegant Foods Carrot Cake Recalled for Unlabeled Food Dyes

    Elegant Foods is recalling Carrot Cakes because the carrot decorations contain Yellow #5 and Yellow #6, which are not listed on the product label.

    Product
    Elegant Foods Carrot Cake, 9". 14 Servings. Keep Refrigerated/Frozen. 537 Atlas Ave., Madison, WI 53714.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3177-2026·2026-09-23

    Wilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues

    Wilson-Cook Medical Inc. is recalling 121,241 units of Hemospray Endoscopic Hemostat due to issues with endoscope adherence and the inability to spray powder.

    Product
    Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3188-2026·2026-09-23

    Boston Scientific StoneSmart Connect Console Power Adapter Recall

    Boston Scientific is recalling StoneSmart Connect Console power adapters that may fail electrical safety testing due to high grounding resistance.

    Product
    Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3172-2026·2026-09-23

    SunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues

    Well Lead Medical Co. Ltd is recalling SunMed Tracheal Tubes because a 6Fr suction catheter could not pass through the samples smoothly.

    Product
    SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2026·2026-09-23

    Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

    Safecor Health is recalling Fluphenazine HCl Elixir because it failed stability specifications. The product is distributed nationwide.

    Product
    Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3157-2026·2026-09-23

    ICU Medical Recalls IV Administration Sets with Drip Chamber Specks

    ICU Medical is recalling IV Non-Dedicated Gravity Administration Sets because black specks in the drip chamber may cause healthcare providers to delay therapy.

    Product
    IV Non-Dedicated Gravity Administration Sets with drip chambers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3180-2026·2026-09-23

    Embecta Medical Recalls Pen Needles Labeled for Investigational Use Only

    Embecta Medical II LLC is recalling pen needles labeled 'For Investigational Use Only' that were inadvertently distributed as commercially marketed devices.

    Product
    EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0844-2026·2026-09-23

    Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

    Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product is distributed nationwide.

    Product
    Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3158-2026·2026-09-23

    ICU Medical Recalls Oncology Sets with Drip Chamber Discoloration

    ICU Medical is recalling 107,800 oncology sets because drip chambers may contain black specks from the molding process, which could lead to product replacement and therapy delays.

    Product
    Oncology sets with drip chambers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0846-2026·2026-09-23

    Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

    Safecor Health is recalling Fluphenazine HCl Elixir because it failed stability specifications. The product was distributed nationwide in the USA.

    Product
    Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3159-2026·2026-09-23

    ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration

    ICU Medical is recalling 28,550 oncology sets because drip chambers may contain black specks from the molding process. The discolored material does not enter the fluid path but may cause therapy delays.

    Product
    Oncology sets with drip chambers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0843-2026·2026-09-23

    Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

    Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product is distributed nationwide in the USA.

    Product
    Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0841-2026·2026-09-23

    Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

    Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product was distributed nationwide.

    Product
    Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·022-2026·2026-09-22

    Star Meat Delivery Recalls Raw Pork, Beef, and Goat Products

    Star Meat Delivery Inc. is recalling raw pork, beef, and goat products produced without federal inspection and bearing false USDA marks.

    Product
    Star Meat Delivery Inc. Recalls Raw Pork, Beef, and Goat Products Produced Without the Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V604000·2026-09-22

    Nova Bus Recalls 2024-2025 LFS Transit Buses for Parking Brake Defect

    Nova Bus is recalling 2024-2025 LFS transit buses because an improperly tightened emergency brake valve may cause air leaks and unintentional parking brake activation.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26E065000·2026-09-22

    Ford Recalls 2024-2026 Ranger Vehicles for Rearview Camera Display Failure

    Ford is recalling 2024-2026 Ranger vehicles with 10.1-inch center stack screens that may lose power and fail to display the rearview camera image, increasing crash risk.

    Product
    BACK OVER PREVENTION:DISPLAY FUNCTION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V606000·2026-09-22

    Ford Recalls 2025-2027 Vehicles for Contaminated Headlight LED Chips

    Ford is recalling specific 2025-2027 Expedition and F-Series Super Duty vehicles because contaminated LED chips in the headlights may cause a loss of exterior lighting, increasing crash risk.

    Product
    FORD — FORD EXPEDITION, F-450 SD, F-350 SD, F-250 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V605000·2026-09-22

    Ford Recalls 2026 Rangers for Rearview Camera Display Failure

    Ford is recalling 2026 Ranger vehicles because the center screen may lose power, preventing the rearview camera image from displaying and increasing crash risk.

    Product
    FORD — FORD RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V603000·2026-09-21

    Forest River Recalls 2026-2027 Dynamax Grand Sport GT Recreational Vehicles

    Forest River is recalling 2026-2027 Dynamax Grand Sport GT recreational vehicles because an improperly installed engine pre-heat pump may cause coolant hose failure and engine overheating.

    Product
    DYNAMAX — DYNAMAX GRAND SPORT GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V600000·2026-09-18

    Volvo Bus 9700 Recall for Missing Emergency Exit Instructions

    Volvo Bus is recalling 2009-2025 9700 buses because the emergency exit label on the entrance door is missing operating instructions, which may delay evacuation.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26779·2026-09-17

    LANCHEZ Pressure Washers Recalled for Shock and Electrocution Hazards

    LANCHEZ pressure washers are recalled because they lack a ground-fault circuit-interrupter and adequate power cord, posing risks of shock or electrocution.

    Product
    LANCHEZ Pressure Washers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V599000·2026-09-17

    Jaguar Land Rover Recalls Vehicles for DC-DC Converter Defect

    Jaguar Land Rover is recalling specific 2019-2024 models because a DC-DC converter malfunction can cause loss of drive power and lighting, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER, JAGUAR RANGE ROVER SPORT, RANGE ROVER VELAR, E-PACE, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26784·2026-09-17

    Sauna360 Recalls Infrared Saunas Due to Fire and Burn Hazards

    Sauna360 is recalling infrared and hybrid saunas because panels can short circuit and overheat, posing fire and burn risks.

    Product
    Infrared Saunas, Hybrid Infrared Saunas and Infrared Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26777·2026-09-17

    Hayward Recalls Universal Pool Heaters Due to Carbon Monoxide Risk

    Hayward Industries is recalling 400,000 BTU Universal-HC Series pool heaters because they can produce high levels of carbon monoxide, posing a risk of serious injury or death.

    Product
    400,000 BTU Universal-HC Series Pool Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26775·2026-09-17

    Esjay Recalls Toddler Busy Board Toys Due to Choking Hazard

    Esjay is recalling toddler busy board toys because red knobs can detach, posing a choking hazard to children under three.

    Product
    Esjay Toddler Busy Board Montessori Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26773·2026-09-17

    Char-Broil Recalls Bistro Pro Electric Grills Due to Electric Shock Risk

    Char-Broil is recalling about 10,605 Bistro Pro Electric Grills because a grounding wire can disconnect, posing an electric shock hazard. No injuries have been reported.

    Product
    Charbroil Bistro Pro Electric Grills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26782·2026-09-17

    SHEIN Recalls Pull and Chew Montessori Teething Toys Due to Choking Hazard

    SHEIN is recalling Pull & Chew Montessori Teething Toys because the silicone strings violate safety standards and pose a choking risk. No injuries have been reported.

    Product
    Pull & Chew Montessori Teething Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26780·2026-09-17

    Melissa & Doug Recalls Fire Truck Activity Board Toys Due to Choking Hazard

    Melissa & Doug is recalling about 84,000 Lights & Sounds Fire Truck Activity Board toys sold at Target and Amazon because a fire hose port can detach, posing a choking risk.

    Product
    Lights & Sounds Fire Truck Activity Board
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0869-2026·2026-09-16

    B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter

    B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection due to the presence of particulate matter, including iron oxide and fibers.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-1330-2026·2026-09-16

    FDA Recalls Gluten-Free Veggie Chips for Undeclared Wheat

    Exotique Foods Canada is recalling Momchipz Gluten Free Veggie Chips due to undeclared wheat. The product was sold in the U.S. and poses a risk to individuals with wheat allergies.

    Product
    Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC 6 28634 44216 6. Ingredients: Broccoli, Cauliflower, Tapioca Flour, Coconut Oil, Salt, White Pepper. Proudly Made in Indonesia. Imported for Exotique Foods, Inc. Toronto, ON - Canada.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-3107-2026·2026-09-16

    Medical Action Industries Recalls Single Shot Epidural Kits Due to Sterility Concerns

    Medical Action Industries is recalling Single Shot Epidural kits containing Sodium Chloride ampules due to potentially compromised sterility.

    Product
    Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
    Category
    Medical Device
    Distribution
    6 states
  • CriticalFDA (Drugs)·D-0865-2026·2026-09-16

    American Regent Recalls Epinephrine Vials Due to Particulate Matter

    American Regent, Inc. is recalling 31,935 vials of Epinephrine Injection due to the presence of particulate matter and broken vials.

    Product
    EPINEPHRINE — EPINEPHRINE (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1341-2026·2026-09-16

    International Sprout Holdings Recalls Alfalfa for Potential E. coli and Salmonella

    International Sprout Holdings is recalling 50 lb. bags of alfalfa due to potential E. coli and Salmonella contamination. The product was distributed to wholesale consignees in 16 states, Puerto Rico, and several international locations.

    Product
    Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506
    Category
    Food
    Distribution
    17 states
  • SevereNHTSA·26V596000·2026-09-16

    Rewaco Recalls Three-Wheeled Motorcycles Due to Rear Shock Absorber Defect

    Rewaco is recalling 106 three-wheeled motorcycles because a rear shock absorber connection may loosen, potentially causing a loss of vehicle control.

    Product
    Rewaco — Rewaco RF1 ST-3 Touring, RF1 GT Touring, PUR3 GT, PUR3 GT Touring
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3133-2026·2026-09-16

    MedicaLyte Liquid Bicarbonate Concentrate Recalled for High Endotoxin Levels

    Nipro Renal Solutions is recalling MedicaLyte Liquid Bicarbonate Concentrate due to high endotoxin levels. The product is used in hemodialysis.

    Product
    MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3106-2026·2026-09-16

    Medical Action Industries Recalls Epidural Kits Due to Compromised Sterility

    Medical Action Industries is recalling Epidural/Pain TQC kits containing Sodium Chloride ampules due to potentially compromised sterility.

    Product
    Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-3136-2026·2026-09-16

    Nipro Citric Complete Liquid Citric Acid Concentrate Recalled for High Endotoxin Levels

    Nipro Renal Solutions is recalling Citric Complete Liquid Citric Acid Concentrate due to high endotoxin levels. The product was distributed in the US and internationally.

    Product
    Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0850-2026·2026-09-16

    Baxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter

    Baxter Healthcare is recalling 606 bags of Dextrose Injection, USP, 70% due to the presence of stainless steel particles in the solution.

    Product
    Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1331-2026·2026-09-16

    Crown Farms Dried Suri Cut Recalled for Improper Evisceration

    Euro Foods Group USA NJ Inc is recalling Crown Farms Dried Suri Cut because the dried fish was not properly eviscerated prior to drying.

    Product
    Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per box, keep frozen
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-3090-2026·2026-09-16

    Given Imaging Recalls Bravo CF Capsule Delivery Devices Due to Attachment Failure

    Given Imaging is recalling Bravo CF capsule delivery devices because they may fail to attach to the esophagus or detach from the device, posing risks of aspiration and perforation.

    Product
    Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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