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.

Agency

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1601–1625 of 30633

HighFDA (Devices)·Z-1611-2026·2026-04-01
[pending] Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Pending LLM rewrite. Source: FDA_DEVICE Z-1611-2026.
Product
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1632-2026·2026-04-01
[pending] Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Pending LLM rewrite. Source: FDA_DEVICE Z-1632-2026.
Product
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1601-2026·2026-04-01
[pending] I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding art
Pending LLM rewrite. Source: FDA_DEVICE Z-1601-2026.
Product
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibul
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1634-2026·2026-04-01
[pending] Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance
Pending LLM rewrite. Source: FDA_DEVICE Z-1634-2026.
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-1638-2026·2026-04-01
[pending] Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutti
Pending LLM rewrite. Source: FDA_DEVICE Z-1638-2026.
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-1593-2026·2026-04-01
[pending] Claviculaplate with Angular Stability, with the below descriptions and associated article numbers.
Pending LLM rewrite. Source: FDA_DEVICE Z-1593-2026.
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-1578-2026·2026-04-01
[pending] DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H7871
Pending LLM rewrite. Source: FDA_DEVICE Z-1578-2026.
Product
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1594-2026·2026-04-01
[pending] Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Hume
Pending LLM rewrite. Source: FDA_DEVICE Z-1594-2026.
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-1622-2026·2026-04-01
[pending] Philips Mini Multi TEE Ultrasound Transducer
Pending LLM rewrite. Source: FDA_DEVICE Z-1622-2026.
Product
Philips Mini Multi TEE Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1624-2026·2026-04-01
[pending] Philips OMNI III TEE Ultrasound Transducer
Pending LLM rewrite. Source: FDA_DEVICE Z-1624-2026.
Product
Philips OMNI III TEE Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1604-2026·2026-04-01
[pending] I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descr
Pending LLM rewrite. Source: FDA_DEVICE Z-1604-2026.
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-1652-2026·2026-04-01
[pending] Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Pending LLM rewrite. Source: FDA_DEVICE Z-1652-2026.
Product
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1633-2026·2026-04-01
[pending] Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Pending LLM rewrite. Source: FDA_DEVICE Z-1633-2026.
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-1595-2026·2026-04-01
[pending] FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Artic
Pending LLM rewrite. Source: FDA_DEVICE Z-1595-2026.
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-1618-2026·2026-04-01
[pending] Philips 3D6-2 Ultrasound Transducer
Pending LLM rewrite. Source: FDA_DEVICE Z-1618-2026.
Product
Philips 3D6-2 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1628-2026·2026-04-01
[pending] Philips X7-2 Ultrasound Transducer
Pending LLM rewrite. Source: FDA_DEVICE Z-1628-2026.
Product
Philips X7-2 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1596-2026·2026-04-01
[pending] Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers.
Pending LLM rewrite. Source: FDA_DEVICE Z-1596-2026.
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-1639-2026·2026-04-01
[pending] Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar
Pending LLM rewrite. Source: FDA_DEVICE Z-1639-2026.
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-1644-2026·2026-04-01
[pending] Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog
Pending LLM rewrite. Source: FDA_DEVICE Z-1644-2026.
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-1631-2026·2026-04-01
[pending] Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Mod
Pending LLM rewrite. Source: FDA_DEVICE Z-1631-2026.
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
HighFDA (Devices)·Z-1619-2026·2026-04-01
[pending] Philips C9-4 Ultrasound Transducer
Pending LLM rewrite. Source: FDA_DEVICE Z-1619-2026.
Product
Philips C9-4 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1567-2026·2026-04-01
[pending] Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Pending LLM rewrite. Source: FDA_DEVICE Z-1567-2026.
Product
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1592-2026·2026-04-01
[pending] Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. A
Pending LLM rewrite. Source: FDA_DEVICE Z-1592-2026.
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-1609-2026·2026-04-01
[pending] MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for us
Pending LLM rewrite. Source: FDA_DEVICE Z-1609-2026.
Product
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1641-2026·2026-04-01
[pending] Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Mode
Pending LLM rewrite. Source: FDA_DEVICE Z-1641-2026.
Product
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electro
Category
Medical Device
Distribution
Distributed nationwide

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1601–1625 of 30633