The Recall Desk

Archive

November 2025 recalls

538 recalls were announced in November 2025.

What the numbers show

Critical
62
Severe
48
High
306
Moderate
118
Low
4

Of the 538 recalls this month scored against our rubric, 12% are Critical, 9% are Severe.

1–100 of 538

  • SevereNHTSA·25V822000·2025-11-28

    Nova Bus Recalls LFS Transit Buses Due to Cooling Pump Defect

    Nova Bus is recalling 2021 and 2024-2025 LFS transit buses because a loose impeller shaft may cause the cooling pump to fail, potentially leading to a loss of drive power and increased crash risk.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0193-2026·2025-11-26

    Raw milk blue cheese recalled over E coli O103 contamination

    Twin Sisters Creamery is recalling 3,438.20 pounds of raw milk Whatcom Blue cheese due to E. coli O103:H2. The FDA has classified the recall as Class I.

    Product
    Twin Sisters Creamery Whatcom Blue cheese, 2.5lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made in Ferndale, WA. www.twinsisterscreamery.com.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-0430-2026·2025-11-26

    Infusion pump modules recalled because drops can damage the bezel assembly

    CareFusion is recalling 2,574,396 BD Alaris Infusion Pump Modules 8100 because a dropped or jarred pump can suffer bezel damage causing under-infusion, over-infusion or unregulated flow.

    Product
    BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Clean
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0201-2026·2025-11-26

    Lobster bisque recalled over undeclared shrimp in bulk foodservice pouches

    Plenus Group is recalling 659 cases of Rockport Lobster Bisque because the product contains undeclared shrimp. The FDA has classified the recall as Class I.

    Product
    Rockport Lobser Bisque; packed in 2x8lb pouches and in 4x4b pouches
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·H-0196-2026·2025-11-26

    Mustard seed raw milk cheese recalled over two E coli strains

    Twin Sisters Creamery is recalling 237.34 pounds of raw milk Mustard Seed cheese due to E. coli O103:H2 and E. coli O74:H25. The FDA classified it Class I.

    Product
    Twin Sisters Creamery Mustard Seed cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: Cultured raw cow's milk, salt, whole yellow mustard seeds and enzymes. Made in Ferndale, WA. www.twinsisterscreamery.com.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-0488-2026·2025-11-26

    Jaw joint implants recalled over a discrepancy in screw hole position

    TMJ Solutions is recalling 63 TMJ Bilateral Implants because the patient-fitted temporomandibular joint implant contained a discrepancy in screw hole position. The FDA classified it Class I.

    Product
    TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    15 states
  • CriticalFDA (Food)·H-0195-2026·2025-11-26

    Peppercorn raw milk cheese recalled over E coli O26 contamination

    Twin Sisters Creamery is recalling 115.46 pounds of raw milk Peppercorn cheese due to E. coli O26:H11. The FDA has classified the recall as Class I.

    Product
    Twin Sisters Creamery Peppercorn cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, whole peppercorns, salt, enzymes. Made in Ferndale, WA. www.twinsisterscreamery.com.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·H-0192-2026·2025-11-26

    Vanilla ice cream recalled over undeclared eggs in four states

    Publix Super Markets is recalling 1,452 units of Publix Rich & Creamy Vanilla Ice Cream over undeclared eggs. The FDA has classified the recall as Class I.

    Product
    Publix Rich & Creamy Vanilla Ice Cream
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0197-2026·2025-11-26

    Whatcom Blue cheese recalled over E coli O103 in raw milk

    Peterson Company is recalling 288 pieces of Twin Sisters Creamery Whatcom Blue cheese due to E. coli O103:H2. The FDA has classified the recall as Class I.

    Product
    Item# 28855 Whatcom Blue, Twin Sisters Creamery brand, product is packed in Cryovac and each package weighs 5oz-6oz. There are 16 pieces per case. This cheese is made from raw milk. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made by Twin Sisters
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0198-2026·2025-11-26

    Farmhouse white cheese recalled over E coli O103 in raw milk

    Peterson Company is recalling 288 pieces of Twin Sisters Creamery Farmhouse White cheese due to E. coli O103:H2. The FDA has classified the recall as Class I.

    Product
    Item# 29608 Farmhouse White, Twin Sisters Creamery brand, product is packed in Cryovac and each package weighs 5oz-6oz. This cheese is made from raw milk. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made by Twin Sisters Creamery in Ferndale, WA.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·H-0194-2026·2025-11-26

    Raw milk farmhouse cheese recalled over two strains of E coli

    Twin Sisters Creamery is recalling 1,359.86 pounds of raw milk Farmhouse Cheese due to E. coli O103:H2 and E. coli O74:H25. The FDA has classified the recall as Class I.

    Product
    Twin Sisters Creamery Farmhouse Cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, salt, and enzymes. Made in Ferndale, WA. www.twinsisterscreamery.com.
    Category
    Food
    Distribution
    2 states
  • SevereCPSC·26120·2025-11-26

    Butane camping stoves recalled after 26 explosions and 16 burn injuries

    About 201,000 Ozark Trail tabletop 1-burner butane camping stoves are being recalled after 26 reports of the stoves exploding or catching fire, including 16 injuries.

    Product
    Ozark Trail Tabletop 1-Burner Butane Camping Stoves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V820000·2025-11-26

    Altec Recalls 2025 LR8 Series Vehicles Due to Bolt Failure Risk

    Altec is recalling 2025 LR8 Series vehicles because improperly formed lockbolts may fail, potentially causing the elevator sub-base to separate from the truck frame.

    Product
    ALTEC — ALTEC LR8 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0522-2026·2025-11-26

    Neuro shunt and laminectomy kits recalled over smoke pencil activation defect

    Medline is recalling 1,315 neurosurgery convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2026·2025-11-26

    Caesarean section kits recalled over smoke pencils that may activate

    Medline is recalling 11,032 C-section convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2026·2025-11-26

    Luer tip caps recalled after trays failed routine biocompatibility testing

    Becton Dickinson is recalling 4,180,000 BD Luer Tip Caps after internal testing confirmed that certain device trays failed routine biocompatibility testing.

    Product
    BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2026·2025-11-26

    Breast and plastics packs recalled over smoke pencils that may activate

    Medline is recalling 4,214 breast, abdominoplasty and plastics convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0574-2026·2025-11-26

    Reprocessed imaging catheters recalled after exceeding validated reprocessing cycles

    Sterilmed is recalling four reprocessed ACUSON AcuNav diagnostic ultrasound catheters because they were reprocessed beyond validated cycles.

    Product
    Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR US
    Category
    Medical Device
    Distribution
    8 states
  • HighCPSC·26125·2025-11-26

    Hair dryers recalled for lacking an immersion protection device

    About 740 MyOnlyStyler Root Booster Hair Dryers are being recalled because they lack an immersion protection device, posing an electrocution risk if dropped in water.

    Product
    MyOnlyStyler Root Booster Hair Dryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26113·2025-11-26

    Macardac baby loungers recalled over fall and entrapment hazards

    About 700 Macardac baby loungers are being recalled because the sides are too low to contain an infant, the foot openings are too wide, and the loungers have no stand.

    Product
    Macardac Baby Loungers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26107·2025-11-26

    Ojaswi fabric dressers recalled over tip over and entrapment hazards

    About 285 Ebern Designs Ojaswi 12-Drawer Dressers are being recalled because they are unstable when not anchored to a wall and violate the STURDY Act standard.

    Product
    Ebern Designs Ojaswi 12-Drawer Dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2026·2025-11-26

    Heart pump kits recalled over corrosion at the backup battery connector

    Thoratec is recalling 29,059 HeartMate 3 Left Ventricular System kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0514-2026·2025-11-26

    Central line and flap packs recalled over smoke pencils that may activate

    Medline is recalling 142 central line and free flap convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0523-2026·2025-11-26

    Major vaginal surgery packs recalled over smoke pencil activation defect

    Medline is recalling 424 major vaginal surgery convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2026·2025-11-26

    Basin packs recalled over smoke pencils that may activate unprompted

    Medline is recalling 1,921 basin convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2026·2025-11-26

    Minor eye trays recalled over smoke pencils that may stay active

    Medline is recalling 345 Minor Eye Tray #81 convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0509-2026·2025-11-26

    ECMO consoles recalled after eleven reports of a blank touchscreen error

    Medtronic is recalling 167 MC3 VitalFlow Consoles after eleven reports of an E70 error code that leaves the touchscreen blank for up to two minutes during operation.

    Product
    MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2026·2025-11-26

    Breast biopsy packs recalled over smoke pencils that may activate

    Medline is recalling 301 breast biopsy and mastectomy convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V821000·2025-11-26

    2025 Nissan Murano vehicles recalled for rearview camera display software fault

    Nissan is recalling certain 2025 Murano and 2025–2026 Armada vehicles, along with 2025–2026 Infiniti QX80 models, due to a software error that may prevent the rearview camera from displaying when the vehicle is in reverse, reducing visibility and increasing crash risk.

    Product
    INFINITI — INFINITI, NISSAN QX80, MURANO, ARMADA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0511-2026·2025-11-26

    Local basic kits recalled over smoke pencils that may stay active

    Medline is recalling 48 LOCAL BASIC convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2026·2025-11-26

    Heart pump implant kits recalled over corrosion at the battery connector

    Thoratec is recalling 248 HeartMate II LVAS Implant Kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.

    Product
    Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The Heart
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0513-2026·2025-11-26

    Vascular and open heart kits recalled over smoke pencils that may activate

    Medline is recalling 5,133 vascular, carotid and open heart convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2026·2025-11-26

    Port insertion packs recalled over smoke pencils that may stay live

    Medline is recalling 12 Port Insertion Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0508-2026·2025-11-26

    HeartMate II controllers recalled over corrosion at the battery connector

    Thoratec is recalling 2,424 HeartMate II Pocket Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.

    Product
    Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The Hea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2026·2025-11-26

    Gynecology surgery kits recalled over smoke pencils that may activate

    Medline is recalling 570 gynecology laparotomy, lithotomy and hysterectomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0572-2026·2025-11-26

    Nephrostomy balloon kits recalled after containing the wrong sized catheter

    Olympus is recalling 60 Nephro-EZDilate nephrostomy balloon catheter kits because they contained a 4mm x 4cm urinary tract balloon instead of the correct 8mm x 15cm nephrostomy balloon.

    Product
    Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0528-2026·2025-11-26

    LEEP procedure packs recalled over smoke pencils that may self activate

    Medline is recalling 18 GP-LEEP convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·26114·2025-11-26

    Pressure mounted safety gates recalled over a torso sized opening

    About 100 Ikuso pressure-mounted safety gates are being recalled because a child's torso can fit through the opening between the gate slat and the side wall.

    Product
    Ikuso Safety Gates
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2026·2025-11-26

    Cell morphology analyzers recalled over barcodes read from the previous slide

    Cellavision is recalling 688 DI-60 automated digital cell morphology analyzers because the barcode reader may read the previous slide's barcode, misattributing diagnostic results.

    Product
    REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2026·2025-11-26

    Heart pump controllers recalled over corrosion at the backup battery connector

    Thoratec is recalling 35,376 HeartMate 3 Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2026·2025-11-26

    Laparotomy kits recalled over smoke pencils that may activate unprompted

    Medline is recalling 28,679 laparotomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2026·2025-11-26

    Non Siemens imaging catheters recalled after exceeding validated reprocessing cycles

    Sterilmed is recalling six reprocessed ACUSON AcuNav diagnostic ultrasound catheters, the variant not for use with Siemens systems, because they were reprocessed beyond validated cycles.

    Product
    Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0516-2026·2025-11-26

    Head and neck ENT kits recalled over smoke pencil activation defect

    Medline is recalling 3,078 head and neck, ENT and thoracotomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0203-2026·2025-11-26

    Cinnamon powder recalled over elevated levels of lead in the spice

    Haitai is recalling 69 cases of Cinnamon Powder in 8 oz containers because of elevated levels of lead.

    Product
    Cinnamon Powder; 8oz clear plastic container. Distributed by Haitai Inc. UPC: 0 20914 81415 9
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0524-2026·2025-11-26

    Gynecology and robotic kits recalled over smoke pencils that may self activate

    Medline is recalling 2,844 gynecology laparoscopy and robotic convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2026·2025-11-26

    Circumcision packs recalled over smoke pencils that may activate unprompted

    Medline is recalling 120 Circumcision Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2026·2025-11-26

    Neuro and joint kits recalled over smoke pencils that may activate

    Medline is recalling 40,151 neurosurgery, back and joint convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2026·2025-11-26

    Bone void implants recalled over an incorrect product name on packaging

    Berkeley Advanced Biomaterials is recalling 62 Tribio Implants 7.5mm x 40mm because the outer packaging carries an incorrect product name.

    Product
    Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2026·2025-11-26

    Flow cytometers recalled over software that crashes during sample acquisition

    Beckman Coulter is recalling 25 DxFLEX Flow Cytometers because a software error crashes the system during acquisition on a patient sample when running a customer defined protocol.

    Product
    DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2026·2025-11-26

    General surgery and knee kits recalled over smoke pencil activation defect

    Medline is recalling 20,941 general surgery, laparoscopy and total knee convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2026·2025-11-26

    Oncology software recalled because appended medication orders may mismatch the schedule

    Elekta is recalling four systems running MOSAIQ Oncology Information System builds 3.1.3 through 3.2.3.0 because appended wave medication orders may not match the intended schedule.

    Product
    MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2026·2025-11-26

    Blood tubes recalled after being manufactured without the gel separator

    Greiner Bio-One is recalling 1,980,000 Vacuette 8 ml serum separator tubes because some were manufactured without the gel separator, which could yield erroneous assay results.

    Product
    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
    Category
    Medical Device
    Distribution
    28 states
  • HighCPSC·26109·2025-11-26

    KingPavonini bed rails recalled over entrapment and asphyxiation risk

    About 81,050 KingPavonini adult portable bed rails are being recalled because users can become entrapped within the rail or between the rail and the mattress.

    Product
    KingPavonini Adult Portable Bed Rails
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0568-2026·2025-11-26

    C difficile test kits recalled over buffer caps missing a gasket

    Meridian Bioscience is recalling alethia C. difficile nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.

    Product
    Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0569-2026·2025-11-26

    Group B strep test kits recalled over buffer caps missing gaskets

    Meridian Bioscience is recalling Group B Streptococcus nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.

    Product
    Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0512-2026·2025-11-26

    Pacemaker packs recalled over smoke pencils that can remain active

    Medline is recalling 12 Cath Lab Pacemaker Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2026·2025-11-26

    Hemostasis valves recalled because the valve cap may remain depressed

    Merit Medical is recalling 217,141 PhD Hemostasis Valves because a manufacturing defect can leave the valve cap depressed, leading to potential leakage and possible hemorrhage.

    Product
    PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-0534-2026·2025-11-26

    Measles antibody tests recalled for being distributed without premarket clearance

    Quest International is recalling ReQuest Measles IgG enzyme linked immunoassay kits because the in vitro diagnostic was distributed without premarket approval or clearance.

    Product
    Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presen
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0162-2026·2025-11-26

    Antifungal cream recalled over contamination found at the same manufacturing facility

    DermaRite Industries is recalling 1,480 packets of DermaFungal antifungal cream because it was made at the same facility where other products and lots were found contaminated.

    Product
    DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0548-2026·2025-11-26

    Three hundred microlitre clot activator tubes recalled over quality system findings

    ASP Global is recalling 6,600 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with clot activator, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0563-2026·2025-11-26

    Balanced heparin capillary tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 121,750 SAFE-T-FILL plastic blood gas capillary tubes, 115 microlitres, over an inadequate quality system with unvalidated processes.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0547-2026·2025-11-26

    Clot activator microtubes recalled over an inadequate quality system

    ASP Global is recalling 27,950 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0170-2026·2025-11-26

    Lanolin skin protectant recalled over contamination found at the manufacturing site

    DermaRite Industries is recalling 57,837 units of Lantiseptic skin protectant because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0544-2026·2025-11-26

    Lithium heparin microtubes recalled over an inadequate quality system

    ASP Global is recalling 78,000 SAFE-T-FILL micro capillary blood collection tubes, 125 microlitres with lithium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0561-2026·2025-11-26

    Larger sodium heparin capillary tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 947,100 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres with sodium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0164-2026·2025-11-26

    Skin protectant ointment recalled over contamination found at its manufacturing facility

    DermaRite Industries is recalling 2,673 tubes of DermaMed Ointment because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0555-2026·2025-11-26

    Microhematocrit capillary tubes recalled over an inadequate quality system

    ASP Global is recalling 2,000 SAFE-T-FILL microhematocrit capillary tubes, 50 microlitres, over an inadequate quality system with unvalidated processes.

    Product
    SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0565-2026·2025-11-26

    Capillary magnetic rings recalled over unvalidated manufacturing processes

    ASP Global is recalling 16,920 SAFE-T-FILL magnetic rings for blood gas capillaries over an inadequate quality system with unvalidated processes.

    Product
    SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2026·2025-11-26

    Lithium heparin capillary tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 103,200 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2026·2025-11-26

    Plasma separator tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 9,150 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0157-2026·2025-11-26

    Cyclosporine eye drops recalled as subpotent across many compounded lots

    Imprimis NJOF is recalling 67,091 bottles of compounded Klarity-C Drops (Cyclosporine) 0.1% preservative-free ophthalmic emulsion as a subpotent drug.

    Product
    Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2026·2025-11-26

    Plasma separator microtubes recalled over an inadequate quality system

    ASP Global is recalling 49,000 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.

    Product
    AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0165-2026·2025-11-26

    External analgesic lotion recalled over contamination found at the same facility

    DermaRite Industries is recalling 2,389 bottles of DermaSarra external analgesic because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0562-2026·2025-11-26

    Sodium heparin blood gas tubes recalled over an inadequate quality system

    ASP Global is recalling 160,250 SAFE-T-FILL plastic blood gas capillary tubes, 230 microlitres with sodium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0567-2026·2025-11-26

    Micro collection tube extenders recalled over an inadequate quality system

    ASP Global is recalling 27,100 SAFE-T-FILL micro collection tube extenders over an inadequate quality system with unvalidated manufacturing processes.

    Product
    SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0564-2026·2025-11-26

    Capillary end caps recalled over an inadequate quality system

    ASP Global is recalling 620,502 SAFE-T-FILL end caps for blood gas capillaries over an inadequate quality system with unvalidated manufacturing processes.

    Product
    SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0178-2026·2025-11-26

    Compounded fentanyl infusion bags recalled over revised quality level interpretation

    Park Avenue Compounding is recalling 189 bags of compounded fentanyl citrate and ropivacaine in sodium chloride for CGMP deviations involving a revised interpretation of AQL results.

    Product
    Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0552-2026·2025-11-26

    Three hundred microlitre heparin tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 6,050 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0539-2026·2025-11-26

    Clotting time cartridges recalled over dried blood on carton labels

    Medtronic is recalling 3,850 HR-ACT clotting time cartridges after trace amounts of dry blood were observed on the external carton label and instructions in five boxes.

    Product
    Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0559-2026·2025-11-26

    Untreated blood gas tubes recalled over an inadequate quality system

    ASP Global is recalling 77,500 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres untreated, over an inadequate quality system.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0566-2026·2025-11-26

    Capillary mixing fleas recalled over an inadequate quality system

    ASP Global is recalling 50,250 mixing fleas for SAFE-T-FILL blood gas capillaries over an inadequate quality system with unvalidated processes.

    Product
    Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2026·2025-11-26

    Sodium fluoride microtubes recalled over an inadequate quality system

    ASP Global is recalling 2,100 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with sodium fluoride, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0177-2026·2025-11-26

    Antiperspirant spray recalled over contamination found elsewhere at the facility

    DermaRite Industries is recalling 37,379 spray bottles of UltraSure Anti-Perspirant & Deodorant because it was made at the same facility where other products were found contaminated.

    Product
    UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0535-2026·2025-11-26

    Shoulder reamers recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 42mm, because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0537-2026·2025-11-26

    Pilot tip converters recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Augments Pilot Tip Converter because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0174-2026·2025-11-26

    Zinc oxide barrier cream recalled over contamination found at the facility

    DermaRite Industries is recalling 37,272 tubes of Renew PeriProtect because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0536-2026·2025-11-26

    Shoulder reamer 46mm recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 46mm, because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
    Category
    Medical Device
    Distribution
    1 state

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