HighFDA (Devices)·Z-2386-2025·2025-09-03
[pending] mL26-8 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2386-2025.
- Product
- mL26-8 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
2551–2575 of 13449
- HighFDA (Devices)·Z-2466-2025·2025-09-03
[pending] AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Numb
Pending LLM rewrite. Source: FDA_DEVICE Z-2466-2025.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SA
- Category
- Medical Device
- Distribution
- 2 states
- 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-2467-2025·2025-09-03
[pending] AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK -
Pending LLM rewrite. Source: FDA_DEVICE Z-2467-2025.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
- Category
- Medical Device
- Distribution
- 2 states
- 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-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-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-2343-2025·2025-09-03
[pending] Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS
Pending LLM rewrite. Source: FDA_DEVICE Z-2343-2025.
- Product
- Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
- 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-2407-2025·2025-09-03
[pending] X3-1 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2407-2025.
- Product
- X3-1 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2438-2025·2025-09-03
[pending] PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Pending LLM rewrite. Source: FDA_DEVICE Z-2438-2025.
- Product
- PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
- Category
- Medical Device
- Distribution
- 0 states
- HighFDA (Devices)·Z-2405-2025·2025-09-03
[pending] VL13-5 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2405-2025.
- Product
- VL13-5 Transducer Probe
- 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-2474-2025·2025-09-03
[pending] STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended f
Pending LLM rewrite. Source: FDA_DEVICE Z-2474-2025.
- Product
- STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. 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) heparins
- 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-2403-2025·2025-09-03
[pending] V6-2 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2403-2025.
- Product
- V6-2 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- 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-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-2384-2025·2025-09-03
[pending] mC7-2 Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2384-2025.
- Product
- mC7-2 Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- 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-2420-2025·2025-09-03
[pending] Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 7
Pending LLM rewrite. Source: FDA_DEVICE Z-2420-2025.
- Product
- Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-2413-2025·2025-09-03
[pending] X8-2t Transducer Probe
Pending LLM rewrite. Source: FDA_DEVICE Z-2413-2025.
- Product
- X8-2t Transducer Probe
- Category
- Medical Device
- Distribution
- Distributed nationwide
- 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-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