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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1476–1500 of 39824

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-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-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-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-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-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-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-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-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-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
ModerateFDA (Devices)·Z-1645-2026·2026-04-01
BD Alaris system labeling omits required TLS version for secure Wi-Fi
CareFusion is recalling the BD Alaris System with Guardrails Suite MX because the product labeling does not indicate which TLS version must be enabled on the hospital network for secure Wi-Fi communication.
Product
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1652-2026·2026-04-01
Embrace standard drill tower surgical technique lists mixed-up article numbers
Waldemar Link is recalling the Embrace Drill Tower, Standard/Lateral, because the surgical technique document has mixed-up article numbers in the instrument overview, although the surgical steps are correct.
Product
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-1651-2026·2026-04-01
Embrace shoulder drill tower surgical technique lists mixed-up article numbers
Waldemar Link is recalling the Embrace Drill Tower because the surgical technique document has mixed-up article numbers in the instrument overview, although the individual surgical steps are correct.
Product
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-1631-2026·2026-04-01
BiDop 3 pocket Doppler labeling includes uncleared fetal indication
Koven Technology is recalling the BiDop 3 Pocket Doppler packaged with a fetal probe because the product labeling includes a fetal indication for use that is not cleared under its 510(k).
Product
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1623-2026·2026-04-01
Philips OMNI II TEE transducer labelling updated to define useful life
Philips is recalling two OMNI II TEE Ultrasound Transducers to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips OMNI II TEE Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1624-2026·2026-04-01
Philips OMNI III TEE transducer labelling updated to define useful life
Philips is recalling the OMNI III TEE Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips OMNI III TEE Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1626-2026·2026-04-01
Philips S5-2 ultrasound transducer labelling updated to define useful life
Philips is recalling one S5-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips S5-2 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1628-2026·2026-04-01
Philips X7-2 ultrasound transducer labelling updated to define useful life
Philips is recalling the X7-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips X7-2 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1622-2026·2026-04-01
Philips Mini Multi TEE transducer labelling updated to define useful life
Philips is recalling the Mini Multi TEE Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips Mini Multi TEE Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1627-2026·2026-04-01
Philips X3-1 ultrasound transducer labelling updated to define useful life
Philips is recalling the X3-1 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips X3-1 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1618-2026·2026-04-01
Philips 3D6-2 ultrasound transducer labelling updated to define useful life
Philips is recalling the 3D6-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips 3D6-2 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1621-2026·2026-04-01
Philips L17-5 ultrasound transducer labelling updated to define useful life
Philips is recalling two L17-5 Ultrasound Transducers to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips L17-5 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1625-2026·2026-04-01
Philips S4-1 ultrasound transducer labelling updated to define useful life
Philips is recalling the S4-1 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips S4-1 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1619-2026·2026-04-01
Philips C9-4 ultrasound transducer labelling updated to define useful life
Philips is recalling one C9-4 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips C9-4 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1620-2026·2026-04-01
Philips L12-5 ultrasound transducer labelling updated to define useful life
Philips is recalling the L12-5 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Product
Philips L12-5 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide

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