The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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1376–1400 of 27375

  • HighFDA (Devices)·Z-1255-2026·2026-02-11

    Backflush instruments recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2026·2026-02-11

    Scleral IOL markers recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2026·2026-02-11

    pTau 217 plasma calibrators recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 117 units of Lumipulse G pTau 217 Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration cu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2026·2026-02-11

    Surgical laser probes recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2026·2026-02-11

    Electrosurgical knives recalled over tip breakage from overheating and burning

    Olympus is recalling the Single Use Electrosurgical Knife KD-640L because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

    Product
    Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2026·2026-02-11

    Ovulation test devices recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 1,000 units of the LH One Step Ovulation Test Device (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    LH One Step Ovulation Test Device (Urine)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2026·2026-02-11

    Oertli laser probes recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2026·2026-02-11

    Insulin pumps recalled over errors that suspend insulin delivery

    Medtronic MiniMed is recalling 577 MiniMed 780G insulin pumps on software version 6.60 because a timing and processor communication issue may trigger Pump Error 43 or 41, suspending insulin delivery.

    Product
    MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1223-2026·2026-02-11

    Electrosurgical knife KD-645 recalled over tip breakage during use

    Olympus is recalling 3,361 Single Use Electrosurgical Knife KD-645 units because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

    Product
    Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1251-2026·2026-02-11

    Retractable membrane polishers recalled over voids in sterile pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Tecfen Retractable Membrane Polisher, QTPR1267-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1261-2026·2026-02-11

    Typhoid antigen tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 1,000 units of the S. Typhi/Para Typhi A Antigen test because it was distributed before it could be legally marketed.

    Product
    S. Typhi/Para Typhi A Antigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2026·2026-02-11

    Exploro fertility tests recalled over missing FDA premarket clearance

    Changchun Wancheng Bio-Electron is recalling 4,800 units of the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2026·2026-02-11

    Single use vitrectomy lenses recalled over voids in pouch seals

    Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.

    Product
    Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2026·2026-02-11

    Vivoo sodium and hydration tests recalled over missing premarket clearance

    Changchun Wancheng Bio-Electron is recalling 3,300 units of Vivoo Sodium Test because tests requiring a 510(k) were distributed before they could be legally marketed.

    Product
    Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2026·2026-02-11

    Knee tibial inserts recalled over a possible packaging discrepancy

    Encore Medical is recalling 19 EMPOWR 3D Knee Tibial Inserts because several acetabular system and knee insert devices may have a packaging discrepancy.

    Product
    EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
    Category
    Medical Device
    Distribution
    14 states
  • CriticalFDA (Devices)·Z-1114-2026·2026-02-04

    Pediatric emergency tapes recalled over potentially harmful drug dosing errors

    SunMed Holdings is recalling 95,300 units of the Broselow Pediatric Emergency Rainbow Tape because the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.

    Product
    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1115-2026·2026-02-04

    Broselow Rainbow Tape 7700RE recalled over potentially harmful dosing errors

    SunMed Holdings is recalling 20,583 units of the Broselow Pediatric Emergency Rainbow Tape, model 7700RE, because it contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.

    Product
    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0417-2026·2026-02-04

    Pediatric ALS organizers recalled over potentially harmful drug dosing errors

    SunMed Holdings is recalling 384 units of the Broselow Domestic Complete ALS Organizer because the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.

    Product
    SOMA KITCHEN NATURAL ASAFOETIDA Net Wt. 4 oz (0.25 lb) Product of India Manufactured for and Imported by: Bharat Bazar, Fremont, CA 94539 Use by : JULY-2027 Lot : NATL/ASFTP/G/24 (BB/ASFTP/G/24) UPC : 4 973993 173586 Ingredients :- Natural Hing
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1117-2026·2026-02-04

    Filled Broselow organizers recalled over potentially harmful dosing errors

    SunMed Holdings is recalling 89 units of the Filled Broselow Organizer, model 7730IALS, because the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.

    Product
    Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Comp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2026·2026-02-04

    Ingenia 3.0T CX systems recalled over elastography stiffness value errors

    Philips North America is recalling 6 units of the Ingenia 3.0T CX MR system because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2026·2026-02-04

    Chest drainage units recalled to limit their use to adults

    Cardinal Health is updating the instructions for use on 1,169,726 chest drainage units to clarify that the intended patient population is adults 18 years and older.

    Product
    Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2026·2026-02-04

    Knotless suture anchors recalled after reports of breakage and pull out

    Aju Pharm is recalling 2,569 AlternatiV+ Max Knotless Anchors after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    AlternatiV+ Max Knotless Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2026·2026-02-04

    Screw-in suture anchors recalled after reports of breakage and bending

    Aju Pharm is recalling 600 units of the Genesis Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Genesis Screw-In Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1213-2026·2026-02-04

    Hybrid suture anchors recalled after reports of breakage and pull out

    Aju Pharm is recalling 233 units of the Fixone Hybrid Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2026·2026-02-04

    Ingenia 3.0T systems recalled over elastography stiffness value errors

    Philips North America is recalling 24 units of the Ingenia 3.0T MR system because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    BEAR Implant. Model Number: 1000.
    Category
    Medical Device
    Distribution
    Distributed nationwide