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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1451–1475 of 39948

  • SevereFDA (Devices)·Z-1615-2026·2026-04-01

    Trilogy Evo O2 ventilator recalled as Class I over tidal volume

    Philips Respironics is recalling the Trilogy Evo O2 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.

    Product
    Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1614-2026·2026-04-01

    Trilogy Evo ventilator recalled as Class I over tidal volume

    Philips Respironics is recalling the Trilogy Evo ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.

    Product
    Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1577-2026·2026-04-01

    Merit 16F splittable sheath introducer recalled as Class I bulk product

    Merit Medical is recalling the 16F Dual Valved Splittable Sheath Introducer in bulk non-sterile form because a design defect may prevent it splitting as intended.

    Product
    16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
    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-1650-2026·2026-04-01

    Puracol collagen wound dressings recalled over elevated endotoxin levels

    Medline is recalling Puracol and Puracol Plus collagen wound dressings after elevated endotoxin levels were identified in affected lots.

    Product
    Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
    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-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-1633-2026·2026-04-01

    Straumann angled custom abutments made from wrong bar material

    Straumann is recalling Custom Abutment AS 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 AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
    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-1612-2026·2026-04-01

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

    Olympus is recalling the OER-Elite 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-Elite. Model Number: N5789340.
    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-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
  • 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-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-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-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-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-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-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-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-1604-2026·2026-04-01

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

    I.T.S. GmbH is recalling the Distal Ulna Locking and Ulna Osteotomy Locking Systems because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1611-2026·2026-04-01

    Olympus endoscope air water valves no longer compatible with named reprocessors

    Olympus is recalling the MAJ-1444 Endoscope Air/Water 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 Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1639-2026·2026-04-01

    Olympus Everest bipolar cutting forceps jaws may break from defective welds

    Olympus is recalling Everest Bipolar 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 Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achi
    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