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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1451–1475 of 39824

  • 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-1606-2026·2026-04-01

    I.T.S. headless compression screws heat more in MRI than stated

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

    Product
    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1636-2026·2026-04-01

    Tandem insulin pump Czech guide inverted a key connection instruction

    Tandem Diabetes Care is recalling insulin pumps distributed in the Czech Republic and Slovakia because the Czech user guide contains translation errors, including one that inverts an infusion set instruction.

    Product
    Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current i
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1592-2026·2026-04-01

    I.T.S. volar radius plates heat more in MRI than stated

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

    Product
    Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2026·2026-04-01

    I.T.S. calcaneus repair plate heats more in MRI than stated

    I.T.S. GmbH is recalling the FR.O.H. Calcaneus Repair System anterolateral calcaneus plate because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2026·2026-04-01

    Olympus OER-Pro reprocessor no longer compatible with two valve models

    Olympus is recalling the OER-Pro Endoscope Reprocessor because the MAJ-1443 and MAJ-1444 air/water valves are no longer reprocessing compatible with the OER-Pro and OER-Elite reprocessors.

    Product
    Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
    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-1632-2026·2026-04-01

    Straumann custom abutments made from wrong bar material after mix-up

    Straumann is recalling Custom Abutment Ti for Straumann RC because a material mix-up meant titanium abutments were manufactured from TAN bar material instead of Titanium Grade 4.

    Product
    Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1610-2026·2026-04-01

    Olympus endoscope suction valve no longer compatible with named reprocessors

    Olympus is recalling the MAJ-1443 Endoscope Suction Valve because the MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

    Product
    Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
    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-1597-2026·2026-04-01

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

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

    Product
    Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2026·2026-04-01

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

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

    Product
    Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 2109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2026·2026-04-01

    TECNIS Eyhance intraocular lens haptic may stick to the optic

    AMO Puerto Rico Manufacturing is recalling TECNIS Eyhance IOLs with the TECNIS Simplicity Delivery System because a limited quantity may have a haptic that sticks to the optic, preventing consistent unfolding.

    Product
    Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2026·2026-04-01

    I.T.S. straight and forearm plates heat more in MRI than stated

    I.T.S. GmbH is recalling Straight Plates with Angular Stability, including forearm and compression plates, because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Pla
    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-1635-2026·2026-04-01

    Medtronic MiniMed 780G software defects may cause insulin delivery inaccuracies

    Medtronic is recalling MiniMed 780G insulin pumps on software 6.60 and 6.61 because three software defects could result in hypoglycemia or hyperglycemia through inaccurate insulin delivery.

    Product
    MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2026·2026-04-01

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

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

    Product
    Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
    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-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-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-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-1590-2026·2026-04-01

    GE Imactis CT navigation may show needle trajectory that differs from actual

    GE Medical Systems is recalling the Imactis CT-Navigation System because of a potential discordance between the simulated needle trajectory and tip position and the actual trajectory and tip position.

    Product
    Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
    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-1644-2026·2026-04-01

    Olympus PKS cutting forceps jaws may break from defective welds

    Olympus is recalling PKS 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 PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visuali
    Category
    Medical Device
    Distribution
    Distributed nationwide