HighFDA (Devices)·Z-0281-2026·2025-10-29
[pending] RADPRO MOBILE, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0281-2026.
- Product
- RADPRO MOBILE, Mobile X-ray system
- Category
- Medical Device
- Distribution
- 3 states
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.
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1951–1975 of 13384
- HighFDA (Devices)·Z-0231-2026·2025-10-29
[pending] MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electroc
Pending LLM rewrite. Source: FDA_DEVICE Z-0231-2026.
- Product
- MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0136-2026·2025-10-29
[pending] Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AI
Pending LLM rewrite. Source: FDA_DEVICE Z-0136-2026.
- Product
- Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-00
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0213-2026·2025-10-29
[pending] GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part
Pending LLM rewrite. Source: FDA_DEVICE Z-0213-2026.
- Product
- GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube
- Category
- Medical Device
- Distribution
- 0 states
- HighFDA (Devices)·Z-0216-2026·2025-10-29
[pending] DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Pending LLM rewrite. Source: FDA_DEVICE Z-0216-2026.
- Product
- DxI 9000 Access Immunoassay Analyzer, Part Number C11137
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0253-2026·2025-10-29
[pending] Model Number 40KWMOBILE3.899, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0253-2026.
- Product
- Model Number 40KWMOBILE3.899, Mobile X-ray system
- Category
- Medical Device
- Distribution
- 3 states
- HighFDA (Devices)·Z-0237-2026·2025-10-29
[pending] BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers:
Pending LLM rewrite. Source: FDA_DEVICE Z-0237-2026.
- Product
- BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0242-2026·2025-10-29
[pending] Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Pending LLM rewrite. Source: FDA_DEVICE Z-0242-2026.
- Product
- Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
- Category
- Medical Device
- Distribution
- 3 states
- HighFDA (Devices)·Z-0292-2026·2025-10-29
[pending] Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Pending LLM rewrite. Source: FDA_DEVICE Z-0292-2026.
- Product
- Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Category
- Medical Device
- Distribution
- 0 states
- HighFDA (Devices)·Z-0249-2026·2025-10-29
[pending] Model Number 40KWFXPLUS.005, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0249-2026.
- Product
- Model Number 40KWFXPLUS.005, Mobile X-ray system
- Category
- Medical Device
- Distribution
- 3 states
- HighFDA (Devices)·Z-0294-2026·2025-10-29
[pending] Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Pending LLM rewrite. Source: FDA_DEVICE Z-0294-2026.
- Product
- Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Category
- Medical Device
- Distribution
- 0 states
- HighFDA (Devices)·Z-0209-2026·2025-10-29
[pending] Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marke
Pending LLM rewrite. Source: FDA_DEVICE Z-0209-2026.
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0300-2026·2025-10-29
[pending] Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Pending LLM rewrite. Source: FDA_DEVICE Z-0300-2026.
- Product
- Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Category
- Medical Device
- Distribution
- 0 states
- HighFDA (Devices)·Z-0274-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0274-2026.
- Product
- Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
- Category
- Medical Device
- Distribution
- 3 states
- HighFDA (Devices)·Z-0070-2026·2025-10-29
[pending] Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalo
Pending LLM rewrite. Source: FDA_DEVICE Z-0070-2026.
- Product
- Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0220-2026·2025-10-29
[pending] Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD
Pending LLM rewrite. Source: FDA_DEVICE Z-0220-2026.
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
- Category
- Medical Device
- Distribution
- 0 states
- HighFDA (Devices)·Z-0247-2026·2025-10-29
[pending] Model Number 40KWFXPLUS.002, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0247-2026.
- Product
- Model Number 40KWFXPLUS.002, Mobile X-ray system
- Category
- Medical Device
- Distribution
- 3 states
- HighFDA (Devices)·Z-0225-2026·2025-10-29
[pending] Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography
Pending LLM rewrite. Source: FDA_DEVICE Z-0225-2026.
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
- Category
- Medical Device
- Distribution
- 0 states
- HighFDA (Devices)·Z-0267-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0267-2026.
- Product
- Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
- Category
- Medical Device
- Distribution
- 3 states
- HighFDA (Devices)·Z-0240-2026·2025-10-29
[pending] BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881.
Pending LLM rewrite. Source: FDA_DEVICE Z-0240-2026.
- Product
- BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0206-2026·2025-10-29
[pending] Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR
Pending LLM rewrite. Source: FDA_DEVICE Z-0206-2026.
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SA
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0262-2026·2025-10-29
[pending] Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0262-2026.
- Product
- Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
- Category
- Medical Device
- Distribution
- 3 states
- HighFDA (Devices)·Z-0236-2026·2025-10-29
[pending] BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packag
Pending LLM rewrite. Source: FDA_DEVICE Z-0236-2026.
- Product
- BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrum
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0265-2026·2025-10-29
[pending] Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0265-2026.
- Product
- Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
- Category
- Medical Device
- Distribution
- 3 states
- HighFDA (Devices)·Z-0260-2026·2025-10-29
[pending] Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0260-2026.
- Product
- Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
- Category
- Medical Device
- Distribution
- 3 states