The Recall Desk

Archive

June 2026 recalls

700 recalls were announced in June 2026.

What the numbers show

Critical
3
Severe
143
High
363
Moderate
189
Low
2

Of the 700 recalls this month scored against our rubric, 0% are Critical, 20% are Severe.

101–200 of 700

  • HighFDA (Devices)·Z-2478-2026·2026-06-24

    Mito Red Light Super Mobile batteries may catch fire

    The Mito Red Light Super Mobile near-infrared therapy device is being recalled because its lithium-ion battery may malfunction, causing it to catch fire or burst into flames.

    Product
    Mito Red Light, Super Mobile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2026·2026-06-24

    Medline red rubber urethral catheters fail applicable performance specifications

    Medline Urethral Catheters in red rubber latex, spanning French sizes 08 to 22, are being recalled because samples did not meet performance specifications. 2,237,471 units affected.

    Product
    MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2026·2026-06-24

    Medline cardiovascular and peripheral vascular packs contain substandard catheters

    Medline CV and peripheral vascular procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,248 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2458-2026·2026-06-24

    Ritmed non-sterile neurological sponges may exceed endotoxin specification for cerebrospinal contact

    Ritmed non-sterile Neurological Sponges across seven sizes are being recalled because they may not consistently meet the endotoxin specification for devices contacting cerebrospinal fluid.

    Product
    Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2500-2026·2026-06-24

    Medline carotid neuro and VP shunt packs contain substandard catheters

    Medline Carotid Neuro Packs and VP Shunt CDS kits are being recalled because representative samples did not meet applicable catheter performance specifications. 342 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2509-2026·2026-06-24

    STAAR ICL calculation software miscalculates toric lens orientation diagram printout

    STAAR ICL Calculation Software version 8.00 is being recalled because of a coding issue in calculating the implantation orientation diagram printout for toric implantable collamer lenses.

    Product
    Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2480-2026·2026-06-24

    Medline 15 Fr urethral catheterization trays fail performance specifications

    Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled because samples did not meet performance specifications. 8,327,756 units are affected.

    Product
    MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2461-2026·2026-06-24

    Stryker Triathlon size 3 baseplate packaging contained a size 4 implant

    Triathlon Universal Baseplate Size 3 packaging is being recalled after Stryker identified that it contained a Size 4 baseplate, and vice versa. Seven units are affected.

    Product
    TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2482-2026·2026-06-24

    Medline red rubber urethral catheterization trays fail performance specifications

    Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots because samples did not meet performance specifications. 235,658 units affected.

    Product
    MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V401000·2026-06-24

    Airstream Recalls 2025-2027 Vehicles Due to Rooftop Fan Fire Risk

    Airstream is recalling 2025-2027 Interstate and 2026 Classic recreational vehicles because a rooftop ventilation fan component may overheat and cause a fire.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE, CLASSIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2507-2026·2026-06-24

    Medline retina procedure kits contain catheters failing performance specifications

    Medline Retina LAC/USC CDS procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 2,340 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS98377
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2026·2026-06-24

    ConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2026·2026-06-24

    Philips Allura Xper hand switch buttons may not fully release

    Philips Allura Xper and MultiDiagnost Eleva systems are being recalled because the hand switch button may not fully release, potentially causing loss of imaging or unintended radiation exposure.

    Product
    Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0593-2026·2026-06-24

    Compounded vasopressin syringes recalled as subpotent by IntegraDose Compounding Services

    Vasopressin 2 Units/2 mL in 0.9% sodium chloride syringes from IntegraDose Compounding Services are being recalled as a subpotent drug. 287 units are affected.

    Product
    Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0949-2026·2026-06-24

    Great Value Hawaiian Rolls Recalled Due to Oily Packaging Substance

    United States Bakery is recalling Great Value Hawaiian Rolls due to an oily and sticky substance found on the packaging's food contact surface. The product was never sold to consumers and all affected product has been accounted for.

    Product
    Great Value Hawaiian Roll 4pk, Item # F63384. Product is perishable dinner roll ready to eat, sold in a corrugated case of 18 packages (4.5oz net wt.) individually wrapped in laminated film. This product was never sold in stores and was never available for consumer purchase. Al
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-2475-2026·2026-06-24

    Giraffe OmniBed incubator canopy fasteners can fall into patient compartment

    Giraffe OmniBed incubator-warmers, all models, are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 19,587 units affected.

    Product
    Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2026·2026-06-24

    ConMed AirSeal 5mm smooth access ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Smooth Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 497 packs, or 2,982 units, are affected.

    Product
    ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2026·2026-06-24

    ConMed AirSeal 12mm palm grip 150mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 150 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2493-2026·2026-06-24

    Medline procedure kits contain catheters failing performance specifications

    Medline medical procedure kits including ECMO chest exploration, coronary artery bypass and D&C/cysto trays are being recalled because sample catheters did not meet performance specifications.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKU DYNJ17321G; 3) D&C/CYSTO, Medline Kit Number/SKU DYNJ909989B; 4) DDD LAPAROSCOPY PACK, Medline Kit Number/SKU D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0947-2026·2026-06-24

    Nutrisystem chocolate cheesecake portions contain undeclared soy allergen

    Nutrisystem Chocolate Cheesecake, 2 oz frozen packages, is being recalled because of undeclared soy. 5,184 units are affected.

    Product
    Nutrisystem, Chocolate Cheesecake, 2 oz (57g) packages, Flow Wrapped, 48 units per case, Keep frozen
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-2497-2026·2026-06-24

    Medline bioburden test and cystectomy kits contain substandard catheters

    Medline procedure kits including the Bioburden Test Kit and Kit Uro Robot Cystectomy are being recalled because sample catheters did not meet performance specifications. 123,030 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0594-2026·2026-06-24

    Aripiprazole 30mg bottle contained voriconazole 50mg tablets instead

    Aripiprazole Tablets USP 30 mg from Ajanta Pharma are being recalled after a bottle containing Voriconazole Tablets 50 mg was labelled and distributed as aripiprazole. 6,143 bottles affected.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2508-2026·2026-06-24

    Medline CRANI procedure kits contain catheters failing performance specifications

    Medline CRANI procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 3,521 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2484-2026·2026-06-24

    Medline coude latex catheters fail applicable performance specifications

    Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 16 Fr, are being recalled across all lots because samples did not meet performance specifications. 10,980 units affected.

    Product
    MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1079-2026·2026-06-24

    Adndale magnesium glycinate gummies contain undeclared melatonin in three lots

    Adndale Magnesium Glycinate Gummies 400 mg are being recalled because of undeclared melatonin. The action covers 13,920 bottles.

    Product
    Adndale Magnesium Glycinate Gummies 400 mg. Plastic bottle containing 90 gummies. Net weight: 11.36 ounces. Serving size: 2 gummies. UPC: 860008784551 Firm name and address listed on label: Dkiru Ltd, Keepers Cottage, 3 Dublin Rd, Leixlip, Co. Kildare W23 H3C4, Ireland
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2477-2026·2026-06-24

    Giraffe OmniBed replaceable units share the canopy fastener disengagement defect

    Giraffe OmniBed Field Replaceable Units are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 265 units affected.

    Product
    Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2026·2026-06-24

    Inspire respiratory sensing leads labeled with Use By dates beyond shelf life

    Inspire Respiratory Sensing Leads, model 4340, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 50 units affected.

    Product
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pres
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2026·2026-06-24

    Medline pelvic laparoscopy packs contain catheters failing performance specifications

    Medline Pelvic Lap Packs are being recalled because representative samples did not meet applicable catheter performance specifications. 20 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2487-2026·2026-06-24

    Medline open heart and cardiac kits contain catheters failing specifications

    Medline open heart and cardiac procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 168,968 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2026·2026-06-24

    HeartMate 11 volt lithium ion backup batteries may fail

    HeartMate 11 Volt Lithium Ion Standalone Backup Batteries, model 106128, are being recalled due to 11 volt backup battery failures. Twelve units are affected.

    Product
    Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2026·2026-06-24

    Inspire stimulation leads labeled with Use By dates beyond shelf life

    Inspire Stimulation Leads, model 4063, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 10 units affected.

    Product
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2492-2026·2026-06-24

    Medline Robinson 22 Fr catheter packs fail performance specifications

    Medline CATH 22F Robinson sterile 5-packs are being recalled because representative samples did not meet applicable catheter performance specifications. 1,000 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2026·2026-06-24

    Stryker Triathlon size 4 baseplate packaging contained a size 3 implant

    Triathlon Universal Baseplate Size 4 packaging is being recalled after Stryker identified that it contained a Size 3 baseplate, and vice versa. Seven units are affected.

    Product
    TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2514-2026·2026-06-24

    BD Connecta stopcock Port C may over thread rather than tightening

    BD Connecta BD Luer-Lok 360 stopcocks, REF 394910, are being recalled because the Port C connection may over thread or spin rather than tightening securely. 2,465,500 units affected.

    Product
    BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-2481-2026·2026-06-24

    Medline pre-connected urethral catheterization trays fail performance specifications

    Medline Pre-connected Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots. The action covers 4,304,669 units.

    Product
    MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND10407
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1076-2026·2026-06-24

    Legacy Tex dressing stabilizer blend tested positive for Salmonella

    Legacy Tex Dressing Stabilizer Blend #7604-50 in 50 lb bags is being recalled because the product tested positive for Salmonella. 546 bags are affected.

    Product
    Legacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2483-2026·2026-06-24

    Medline 14 Fr coude latex catheters fail performance specifications

    Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 14 Fr, are being recalled across all lots because samples did not meet performance specifications. 8,260 units affected.

    Product
    MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2026·2026-06-24

    HeartMate 3 system controllers recalled over backup battery failures

    HeartMate 3 System Controllers, model 106531US, are being recalled due to 11 volt backup battery failures. 694 units are affected.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2474-2026·2026-06-24

    ConMed AirSeal 12mm palm grip 100mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports with Palm Grip Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2026·2026-06-24

    TRIGEN proximal humeral nails are missing their distal holes

    TRIGEN Proximal Straight Humeral Nails 8/7 x 16 are being recalled because a manufacturing error left them missing distal holes. Five units are affected.

    Product
    TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2505-2026·2026-06-24

    Medline gynaecology procedure packs contain catheters failing performance specifications

    Medline gynaecology procedure packs including hysteroscopy, D&C and tubal ligation kits are being recalled because sample catheters did not meet performance specifications. 37,324 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2026·2026-06-24

    ConMed AirSeal 12mm access ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 891 packs, or 5,346 units, are affected.

    Product
    ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0596-2026·2026-06-24

    Buprenorphine injection vials show crystallization identified as buprenorphine free base

    Buprenorphine HCl Injection, 0.3 mg/mL single dose vials, is being recalled because of crystallization identified as buprenorphine free base. 46,334 units are affected.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2506-2026·2026-06-24

    Medline urology and gynaecology kits contain catheters failing specifications

    Medline procedure kits including robotic cystectomy, D&C and lithotomy packs are being recalled because sample catheters did not meet performance specifications. 32,438 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2451-2026·2026-06-24

    Medtronic O-arm O2 imaging systems may produce image artifacts

    Medtronic O-arm O2 Imaging Systems are being recalled because an anomaly in the detector panel firmware may cause image artifacts. 589 units are affected.

    Product
    Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2518-2026·2026-06-24

    HeartMate 3 assist system kits recalled over backup battery failures

    HeartMate 3 Left Ventricular Assist System kits, model 106524US, are being recalled due to 11 volt backup battery failures. Four units are affected.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2418-2026·2026-06-24

    Medline pacemaker and open heart packs contain recalled Mastisol adhesive

    Medline convenience kits including pacemaker, ICD, open heart and pediatric open heart packs are being recalled over a recalled lot of Mastisol Liquid Adhesive.

    Product
    Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2460-2026·2026-06-24

    directCHECK whole blood control labeled with incorrect performance range

    directCHECK ACT-LR whole blood quality control, level 2, is being recalled because the assayed control carries labeling with an incorrect performance range. 6,060 units affected.

    Product
    directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0638-2026·2026-06-24

    Med Pride clotrimazole antifungal cream recalled over manufacturing practice deviations

    Med Pride 1% Clotrimazole Antifungal Cream, 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 5,755 tubes are affected.

    Product
    Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2427-2026·2026-06-24

    Medline hernia repair totes contain recalled Mastisol liquid adhesive

    The Medline Hernia Repair Tote convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.

    Product
    Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0631-2026·2026-06-24

    Circle K triple antibiotic ointment recalled over manufacturing practice deviations

    Circle K Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 2,420 tubes are affected.

    Product
    Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0588-2026·2026-06-24

    Alyacen 7/7/7 birth control tablets failed total impurities specification

    Alyacen 7/7/7 norethindrone and ethinyl estradiol tablets are being recalled because of out-of-specification results for total impurities.

    Product
    ALYACEN 1/35 — ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2430-2026·2026-06-24

    Medline pelviscopy packs contain recalled Mastisol liquid adhesive

    The Medline SMSC Pelviscopy Pack-LF is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.

    Product
    Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0637-2026·2026-06-24

    Med Pride bacitracin zinc ointment recalled over manufacturing practice deviations

    Med Pride Bacitracin Zinc Ointment, 1 oz tubes, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,185 tubes affected.

    Product
    Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2422-2026·2026-06-24

    Medline abdominal and bariatric packs contain recalled Mastisol liquid adhesive

    Medline convenience kits including abdominal, bariatric and laparoscopic cholecystectomy packs are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.

    Product
    Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECTOMY DYNJ910459B CHRISTUS CHILDRENS LAP CHOLE DYNJ61165G CUH MINOR PACK-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0591-2026·2026-06-24

    Kerr Insta-Char activated charcoal suspension did not meet OTC monograph

    VistaPharm Kerr Insta-Char activated charcoal in a sorbitol base with cherry flavor is being recalled because the product did not meet the Over-the-Counter Monograph M023.

    Product
    VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2444-2026·2026-06-24

    Medline vascular and cardiac packs contain recalled Mastisol liquid adhesive

    Medline convenience kits including AV fistula, endovascular, EP device and aneurysm packs are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.

    Product
    Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2434-2026·2026-06-24

    Medline da Vinci main kits contain recalled Mastisol liquid adhesive

    Medline da Vinci Main convenience kits are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.

    Product
    Medline convenience kits: DAVINCI MAIN DYNJ908031D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2442-2026·2026-06-24

    Medline femoral block trays contain recalled Mastisol liquid adhesive

    The Medline Femoral Block Tray is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.

    Product
    Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0606-2026·2026-06-24

    Safco SensiCaine-Ultra benzocaine gel bottles may have incomplete seals

    Safco SensiCaine-Ultra Topical Anesthetic Gel, 20% benzocaine strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 150 units affected.

    Product
    SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL — SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2445-2026·2026-06-24

    Medline arterial insertion and PICC dressing trays contain recalled Mastisol

    The Medline Add-A-Cath Arterial Insertion kit and Ped School Age PICC Dressing Tray are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.

    Product
    Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0633-2026·2026-06-24

    Rapidol triple antibiotic first aid ointment recalled over manufacturing deviations

    Rapidol Triple Antibiotic First Aid Ointment, 2 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 84 tubes are affected.

    Product
    Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0589-2026·2026-06-24

    Kerr Insta-Char 25 gram aqueous suspension did not meet OTC monograph

    VistaPharm Kerr Insta-Char in an aqueous base, 25 grams activated charcoal, is being recalled because the product did not meet Over-the-Counter Monograph M023.

    Product
    VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2429-2026·2026-06-24

    Medline labor and delivery C-section kits contain recalled Mastisol adhesive

    The Medline Labor & Delivery C-Section convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.

    Product
    Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2420-2026·2026-06-24

    Medline breast hernia port kits contain recalled Mastisol liquid adhesive

    The Medline Breast-Hernia-Port CDS-LF kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.

    Product
    Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0604-2026·2026-06-24

    Dental City benzocaine anesthetic gel bottles may have incomplete seals

    Dental City Topical Anesthetic Gel, benzocaine 20% strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 450 units are affected.

    Product
    DENTAL CITY TOPICAL ANESTHETIC — DENTAL CITY TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0601-2026·2026-06-24

    Quala Dental benzocaine anesthetic gel bottles may have incomplete seals

    Quala Dental Products Topical Anesthetic Gel, 20% benzocaine strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 150 units affected.

    Product
    QUALA TOPICAL ANESTHETIC GEL — QUALA TOPICAL ANESTHETIC GEL (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0642-2026·2026-06-24

    Med Pride triple antibiotic ointment tubes recalled over manufacturing deviations

    Med Pride Triple Antibiotic Ointment in 1 oz tubes is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 8,996 tubes are affected.

    Product
    Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2431-2026·2026-06-24

    Medline da Vinci and gynaecology laparoscopy kits contain recalled Mastisol

    Medline da Vinci, general robotics and gynaecology laparoscopy convenience kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.

    Product
    Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS982371I GYN LAPAROSCOPY CDS #34-RF CDS920099S GYN LAPAROSCOPY PACK DYNJT3887
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2433-2026·2026-06-24

    Medline LAVH packs contain recalled Mastisol liquid adhesive

    The Medline WT LAVH Pack is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.

    Product
    Medline convenience kits: WT LAVH PACK DYNJ46609F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2449-2026·2026-06-24

    HarmonyAIR A-Series surgical light intensity control buttons may detach

    HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the plus and minus buttons used to control light intensity on the light heads may detach. 2,101 units affected.

    Product
    HarmonyAIR A-Series Surgical Lighting System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2026·2026-06-24

    Medline arthroscopy and paediatric kits contain recalled Mastisol adhesive

    Medline convenience kits for ACL, arthroscopy, back and paediatric procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.

    Product
    Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007 BASIC ACCESS PACK-LF DYNJ36698B BASIC BACK TRAY DYNJ89037 BASIC PEDI PACK-LF DYNJ0171446I DYNJ0171446J BASIC SPINE DYNJ910915A BREAST PACK DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0634-2026·2026-06-24

    Cura Hongos clotrimazole cream recalled over manufacturing practice deviations

    Cura Hongos Crema Antifungica, clotrimazole 1%, in 2 oz tubes is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 84 tubes affected.

    Product
    Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0600-2026·2026-06-24

    Pearson Quality benzocaine anesthetic gel bottles may have incomplete seals

    Pearson Quality Topical Anesthetic Gel, 20% benzocaine mint flavor, is being recalled because the product may contain bottles with incomplete seals. 900 units are affected.

    Product
    PEARSON TOPICAL ANESTHETIC — PEARSON TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2026·2026-06-24

    Medline cath lab and angio packs contain recalled Mastisol adhesive

    Medline Minor Cath Lab Packs, OR Vascular Angio Packs and Port-A-Cath kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.

    Product
    MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0632-2026·2026-06-24

    Lil Drug Store triple antibiotic ointment recalled over manufacturing deviations

    Lil Drug Store Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,225 tubes affected.

    Product
    Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2428-2026·2026-06-24

    Medline neurosurgery convenience kits contain recalled Mastisol liquid adhesive

    Medline neurosurgery convenience kits including neuro packs, MRI DBS packs and VP shunt kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.

    Product
    Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2437-2026·2026-06-24

    Centurion dialysis and dressing change kits contain recalled Mastisol adhesive

    Centurion convenience kits including dialysis catheter maintenance and dressing change trays are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.

    Product
    Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B DIALYSIS CATHETER MAINTENANCE KIT DT17570 DIALYSIS DRESSING CHANGE KIT DT21370B DRESSING CHANGE TRAY - GOLD DT21115B PORT DRESSING CHANGE KIT DYNDC2815A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0590-2026·2026-06-24

    Kerr Insta-Char aqueous charcoal suspension did not meet OTC monograph

    VistaPharm Kerr Insta-Char in an aqueous base, 50 grams activated charcoal, is being recalled because the product did not meet Over-the-Counter Monograph M023.

    Product
    VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2438-2026·2026-06-24

    Medline EBSI dressing change kits contain recalled Mastisol liquid adhesive

    Medline EBSI central line, CVC/PICC/midline and dialysis dressing change kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.

    Product
    Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0639-2026·2026-06-24

    Med Pride hydrocortisone cream 16oz tubes recalled over manufacturing deviations

    Med Pride Hydrocortisone Cream 1%, 16 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,738 tubes are affected.

    Product
    Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0592-2026·2026-06-24

    Kerr Insta-Char 50 gram charcoal suspension did not meet OTC monograph

    VistaPharm Kerr Insta-Char, 50 grams activated charcoal in a sorbitol base, is being recalled because the product did not meet Over-the-Counter Monograph M023.

    Product
    VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2026·2026-06-24

    Lucky Super Soft athlete's foot cream recalled over manufacturing deviations

    Lucky Super Soft Antifungal Athlete's Foot Cream, clotrimazole 1%, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,102 tubes affected.

    Product
    Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0630-2026·2026-06-24

    Lucky Super Soft triple antibiotic ointment recalled over manufacturing deviations

    Lucky Super Soft First Aid Triple Antibiotic Ointment, 0.5 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 2,503 tubes are affected.

    Product
    Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2439-2026·2026-06-24

    Medline CVC insertion kits contain recalled Mastisol liquid adhesive

    Medline central venous catheter insertion kits and Vantex PI CVC bundles are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.

    Product
    Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0640-2026·2026-06-24

    Med Pride hydrocortisone cream 1oz tubes recalled over manufacturing deviations

    Med Pride Hydrocortisone Cream 1%, 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,944 tubes are affected.

    Product
    Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0602-2026·2026-06-24

    DHP benzocaine topical anesthetic gel bottles may have incomplete seals

    DHP Topical Anesthetic Gel, benzocaine 20% strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 150 units are affected.

    Product
    HEALTH-TEC TOPICAL ANESTHETIC — HEALTH-TEC TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2425-2026·2026-06-24

    Medline IV start kits with HubGuard contain recalled Mastisol adhesive

    The Medline IV Start Kit with HubGuard is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.

    Product
    Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2435-2026·2026-06-24

    Medline basic eye and tubal ligation kits contain recalled Mastisol

    The Medline Basic Eye kit and Tubal Ligation CDS kit are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.

    Product
    Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2415-2026·2026-06-24

    Medline nerve block trays contain recalled Mastisol liquid adhesive

    Medline CCI Nerve Block Trays and CPNB kits are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.

    Product
    Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2443-2026·2026-06-24

    Medline Port A Cath kits contain recalled Mastisol liquid adhesive

    The Medline Port A Cath convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.

    Product
    Medline convenience kits: PORT A CATH DYNJ906818A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0641-2026·2026-06-24

    Med Pride triple antibiotic ointment packets recalled over manufacturing deviations

    Med Pride Triple Antibiotic Ointment in 0.9 g packets is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 3,006 tubes affected.

    Product
    Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0603-2026·2026-06-24

    Burkhart benzocaine topical anesthetic gel bottles may have incomplete seals

    Burkhart topical anesthetic gel, benzocaine 20% strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 150 units are affected.

    Product
    BURKHART TOPICAL ANESTHETIC — BURKHART TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2421-2026·2026-06-24

    Medline ENT and ear procedure kits contain recalled Mastisol adhesive

    Medline convenience kits for discectomy, ear, ENT and head and neck procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.

    Product
    Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0635-2026·2026-06-24

    Med Pride bacitracin zinc packets recalled over manufacturing practice deviations

    Med Pride Bacitracin Zinc Ointment, 500 units in 0.9 g packets, is being recalled because of CGMP deviations observed during an FDA inspection. 1,087 tubes affected.

    Product
    Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0951-2026·2026-06-24

    Fairhope Cold Brew Coffee Concentrate Recall Over Missing Refrigeration Label

    Fairhope Roasting Company is recalling its Cold Brew Coffee Concentrate distributed in Alabama for food service because the label is missing a required "Keep Refrigerated" statement.

    Product
    Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs, UPC 852236006062, for food service only
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2447-2026·2026-06-24

    Medline hysterectomy packs contain recalled Mastisol liquid adhesive

    The Medline Hysterectomy Pack-LF is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.

    Product
    Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L
    Category
    Medical Device
    Distribution
    Distributed nationwide

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