HighFDA (Devices)·Z-2371-2025·2025-09-03
[pending] L11-3 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2371-2025.
- Product
- L11-3 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
2501–2525 of 13463
- HighFDA (Devices)·Z-2422-2025·2025-09-03
[pending] Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 68020
Pending LLM rewrite. Source: FDA_DEVICE Z-2422-2025.
- Product
- Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring che
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2369-2025·2025-09-03
[pending] eL18-4 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2369-2025.
- Product
- eL18-4 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2396-2025·2025-09-03
[pending] S7-2t Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2396-2025.
- Product
- S7-2t Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2383-2025·2025-09-03
[pending] mC12-3 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2383-2025.
- Product
- mC12-3 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2393-2025·2025-09-03
[pending] S4-2 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2393-2025.
- Product
- S4-2 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2440-2025·2025-09-03
[pending] Orascoptic Superior Visualization Custom loupes with Dragonfly frames
Pending LLM rewrite. Source: FDA_DEVICE Z-2440-2025.
- Product
- Orascoptic Superior Visualization Custom loupes with Dragonfly frames
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2452-2025·2025-09-03
[pending] The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care
Pending LLM rewrite. Source: FDA_DEVICE Z-2452-2025.
- Product
- The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2401-2025·2025-09-03
[pending] Transducer C10-3v Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2401-2025.
- Product
- Transducer C10-3v Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2464-2025·2025-09-03
[pending] AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, M
Pending LLM rewrite. Source: FDA_DEVICE Z-2464-2025.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, M
- Category
- Medical Device
- Distribution
- 2 states
- HighFDA (Devices)·Z-2357-2025·2025-09-03
[pending] C8-4v Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2357-2025.
- Product
- C8-4v Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2415-2025·2025-09-03
[pending] Spectrum IQ Infusion Pump, Product Code 3570009
Pending LLM rewrite. Source: FDA_DEVICE Z-2415-2025.
- Product
- Spectrum IQ Infusion Pump, Product Code 3570009
- Category
- Medical Device
- Distribution
- 2 states
- HighFDA (Devices)·Z-2461-2025·2025-09-03
[pending] IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE Syst
Pending LLM rewrite. Source: FDA_DEVICE Z-2461-2025.
- Product
- IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE S
- Category
- Medical Device
- Distribution
- 25 states
- HighFDA (Devices)·Z-2411-2025·2025-09-03
[pending] X7-2 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2411-2025.
- Product
- X7-2 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2391-2025·2025-09-03
[pending] S4-1 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2391-2025.
- Product
- S4-1 Transducer Probe
- 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-2470-2025·2025-09-03
[pending] AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODE
Pending LLM rewrite. Source: FDA_DEVICE Z-2470-2025.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
- Category
- Medical Device
- Distribution
- 2 states
- HighFDA (Devices)·Z-2346-2025·2025-09-03
[pending] 3D6-2 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2346-2025.
- Product
- 3D6-2 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2471-2025·2025-09-03
[pending] AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL
Pending LLM rewrite. Source: FDA_DEVICE Z-2471-2025.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
- Category
- Medical Device
- Distribution
- 2 states
- HighFDA (Devices)·Z-2417-2025·2025-09-03
[pending] Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Pro
Pending LLM rewrite. Source: FDA_DEVICE Z-2417-2025.
- Product
- Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature
- Category
- Medical Device
- Distribution
- Distributed nationwide
- 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
- 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-2348-2025·2025-09-03
[pending] 7.5MHZ Endo Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2348-2025.
- Product
- 7.5MHZ Endo Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2469-2025·2025-09-03
[pending] AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, M
Pending LLM rewrite. Source: FDA_DEVICE Z-2469-2025.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
- Category
- Medical Device
- Distribution
- 2 states
- 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