HighFDA (Devices)·Z-2354-2025·2025-09-03
[pending] C5-2 Lumify Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2354-2025.
- Product
- C5-2 Lumify Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
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.
Filters
Minimum severity
2526–2550 of 13449
- HighFDA (Devices)·Z-2423-2025·2025-09-03
[pending] ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Pending LLM rewrite. Source: FDA_DEVICE Z-2423-2025.
- Product
- ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2477-2025·2025-09-03
[pending] BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629
Pending LLM rewrite. Source: FDA_DEVICE Z-2477-2025.
- Product
- BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2451-2025·2025-09-03
[pending] Akreos, SKU: AO60P0300. Akreos intraocular lenses
Pending LLM rewrite. Source: FDA_DEVICE Z-2451-2025.
- Product
- Akreos, SKU: AO60P0300. Akreos intraocular lenses
- Category
- Medical Device
- Distribution
- 2 states
- HighFDA (Devices)·Z-2382-2025·2025-09-03
[pending] L9-3 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2382-2025.
- Product
- L9-3 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2351-2025·2025-09-03
[pending] C10-4ec Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2351-2025.
- Product
- C10-4ec Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2442-2025·2025-09-03
[pending] Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe,
Pending LLM rewrite. Source: FDA_DEVICE Z-2442-2025.
- Product
- Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2358-2025·2025-09-03
[pending] C8-4v Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2358-2025.
- Product
- C8-4v Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2475-2025·2025-09-03
[pending] STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended
Pending LLM rewrite. Source: FDA_DEVICE Z-2475-2025.
- Product
- STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparin
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2388-2025·2025-09-03
[pending] OMNI III TEE Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2388-2025.
- Product
- OMNI III TEE Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2379-2025·2025-09-03
[pending] L17-5 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2379-2025.
- Product
- L17-5 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2377-2025·2025-09-03
[pending] L15-7io Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2377-2025.
- Product
- L15-7io Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2462-2025·2025-09-03
[pending] Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Cathe
Pending LLM rewrite. Source: FDA_DEVICE Z-2462-2025.
- Product
- Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2445-2025·2025-09-03
[pending] Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 2
Pending LLM rewrite. Source: FDA_DEVICE Z-2445-2025.
- Product
- Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2360-2025·2025-09-03
[pending] C9-2 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2360-2025.
- Product
- C9-2 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2363-2025·2025-09-03
[pending] C9-4 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2363-2025.
- Product
- C9-4 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2421-2025·2025-09-03
[pending] Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 680
Pending LLM rewrite. Source: FDA_DEVICE Z-2421-2025.
- Product
- Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure wit
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2390-2025·2025-09-03
[pending] S3-1 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2390-2025.
- Product
- S3-1 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2406-2025·2025-09-03
[pending] X11-4t Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2406-2025.
- Product
- X11-4t Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2350-2025·2025-09-03
[pending] C10-3v Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2350-2025.
- Product
- C10-3v Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2341-2025·2025-09-03
[pending] GE HealthCare OEC 9800.
Pending LLM rewrite. Source: FDA_DEVICE Z-2341-2025.
- Product
- GE HealthCare OEC 9800.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2359-2025·2025-09-03
[pending] C8-5 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2359-2025.
- Product
- C8-5 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2349-2025·2025-09-03
[pending] BP10-5ec Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2349-2025.
- Product
- BP10-5ec Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2366-2025·2025-09-03
[pending] D2cwc Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2366-2025.
- Product
- D2cwc Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2402-2025·2025-09-03
[pending] TRANSDUCER L12-5 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2402-2025.
- Product
- TRANSDUCER L12-5 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide