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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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1101–1125 of 27375

  • HighFDA (Devices)·Z-1607-2026·2026-04-01

    I.T.S. hand locking plates heat more in MRI than instructions state

    I.T.S. GmbH is recalling the HLS Hand Locking Plates System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2026·2026-04-01

    Orthalign knee drill plates may allow a bone cut exceeding specification

    Orthalign is recalling one lot of the Trimax Pegged Drill Plate for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.

    Product
    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2026·2026-04-01

    I.T.S. pelvic reconstruction plates heat more in MRI than stated

    I.T.S. GmbH is recalling the Pelvic Reconstruction System PRS RX and PRS Phoenix because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2026·2026-04-01

    I.T.S. femur and tibia plates heat more in MRI than stated

    I.T.S. GmbH is recalling the LRS Locking Reconstruction System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2026·2026-04-01

    Olympus PKS cutting forceps 3005PK jaws may break from defective welds

    Olympus is recalling PKS Cutting Forceps model 3005PK because a supplier did not adequately validate the welding process and defective welds can cause the jaw to break during clinical use.

    Product
    Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualiza
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2026·2026-04-01

    Olympus Everest bipolar forceps model 3005 jaws may break

    Olympus is recalling Everest Bipolar Cutting Forceps model 3005 because a supplier did not adequately validate the welding process, and defective welds can cause the jaw to break during clinical use.

    Product
    Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2026·2026-04-01

    Olympus PK cutting forceps jaws may break from defective welds

    Olympus is recalling PK Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2026·2026-04-01

    I.T.S. clavicle plates heat more in MRI than instructions state

    I.T.S. GmbH is recalling Clavicula Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2026·2026-04-01

    I.T.S. cannulated screw system heats more in MRI than stated

    I.T.S. GmbH is recalling the I.T.S. Screw System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 314
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2026·2026-04-01

    Orthalign drill plate sizes 1-5 may allow excessive bone cut

    Orthalign is recalling one lot of the Trimax Pegged Drill Plate sizes 1-5 for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.

    Product
    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2026·2026-04-01

    Olympus PKS cutting forceps 920000PK jaws may break from welds

    Olympus is recalling PKS Cutting Forceps with cord, model 920000PK, because a supplier did not adequately validate the welding process and defective welds can cause the jaw to break.

    Product
    Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2026·2026-04-01

    I.T.S. distal humeral plates heat more in MRI than stated

    I.T.S. GmbH is recalling Distal Humeral Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 373
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2026·2026-04-01

    I.T.S. foot locking plates heat more in MRI than stated

    I.T.S. GmbH is recalling the FLS Foot Locking Plates System and HOL Hallux Osteotomy Locking Plate because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 373
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2026·2026-03-25

    ConvaTec EsteemBody drainable pouch REF 423657 may leak

    ConvaTec is recalling one lot of the EsteemBody Drainable Pouch, REF 423657, because the drainable large pouch may leak due to a manufacturing issue.

    Product
    Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2026·2026-03-25

    Hologic Aptima HPV assay may produce invalid or false negative results

    Hologic is recalling one master lot of the Aptima HPV Assay because the product exhibits potential to generate either invalid or false negative results.

    Product
    Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1570-2026·2026-03-25

    GE Centricity Viewer 6.0 may expose login credentials on workstations

    GE Medical Systems is recalling Centricity Universal Viewer software versions 6.0 through 6.0 SP10.4.1 because user login credentials may be exposed on the local client workstation.

    Product
    Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2026·2026-03-25

    GE Centricity Viewer 7.0 may expose login credentials on workstations

    GE Medical Systems is recalling Centricity Universal Viewer software versions 7.0 through 7.0 SP2.0.1 because user login credentials may be exposed on the local client workstation.

    Product
    Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2026·2026-03-25

    Welch Allyn vision screener display may flicker inducing photosensitive seizures

    Baxter is recalling the Welch Allyn Spot Vision Screener VS100 on software version 3.2.0.1 because the display screen may unintentionally flicker, which may induce photosensitive seizure activity.

    Product
    Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit pe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2026·2026-03-25

    Stago D-dimer assay shows positive bias across entire analytical range

    Diagnostica Stago is recalling the STA Liatest D-Di kit after investigations confirmed a positive bias in D-dimer measurements throughout the entire analytical range.

    Product
    Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Sat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2026·2026-03-25

    ConvaTec EsteemBody drainable pouch REF 423653 may leak

    ConvaTec is recalling one lot of the EsteemBody Drainable Pouch, REF 423653, because the drainable large pouch may leak due to a manufacturing issue.

    Product
    Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2026·2026-03-25

    ConvaTec EsteemBody drainable pouch REF 423643 may leak

    ConvaTec is recalling two lots of the EsteemBody Drainable Pouch, REF 423643, because the drainable large pouch may leak due to a manufacturing issue.

    Product
    Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2026·2026-03-25

    Abbott ID NOW influenza test lot shows higher invalid result rates

    Abbott is recalling one lot of the ID NOW Influenza A & B 2 test after confirming the lot has a higher occurrence of invalid rates than stated in the Instructions for Use.

    Product
    Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2026·2026-03-25

    Stryker sagittal saw attachment cover screws may loosen and detach

    Howmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment because the external screws securing the cover to the saw housing may loosen and detach during use.

    Product
    MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2026·2026-03-25

    Leksell Gamma Knife recalled over adapter not properly aligned or locked

    Elekta is recalling Leksell Gamma Knife radiosurgery systems, covering the Perfexion, Icon and Elekta Esprit models, due to an adapter not being properly aligned or locked in place.

    Product
    Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2026·2026-03-25

    GE Centricity Viewer 5.0 may expose login credentials on workstations

    GE Medical Systems is recalling Centricity Universal Viewer software versions 5.0 SP6 through 5.0 SP7.1 because user login credentials may be exposed on the local client workstation.

    Product
    Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2
    Category
    Medical Device
    Distribution
    Distributed nationwide