SEDECAL SA: 53 FDA recall reports
Every medical device recall the FDA has published for SEDECAL SA. The fault, and how the agency graded it.
53Reports
0Class I
53Ongoing
2025-10-29Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Z-0243-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 1198 units
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
Z-0255-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 8 units
Model Number 40KWFXPLUS.004, Mobile X-ray system
Z-0248-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number 40KWFXPLUS.004, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 3 units
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Z-0270-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 4 units
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
Z-0277-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 142 units
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Z-0271-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 181 units
SM_40HF_B_D_VIR3, Mobile X-ray system
Z-0284-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- SM_40HF_B_D_VIR3, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 17 units
SM_40HF_BDC3, Mobile X-ray system
Z-0287-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- SM_40HF_BDC3, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 1 unit
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Z-0254-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 1 unit
SHIMADZU RF.004, Mobile X-ray system
Z-0283-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- SHIMADZU RF.004, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
Z-0278-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 6 units
Model Number 40KW-FX.899, Mobile X-ray system
Z-0245-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number 40KW-FX.899, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 1 unit
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
Z-0252-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 7 units
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
Z-0257-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 6 units
Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
Z-0279-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 6 units
SM_40HF_B_D_VIR3.004, Mobile X-ray system
Z-0285-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- SM_40HF_B_D_VIR3.004, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 3 units
Model Number 40KWFXPLUS.889, Mobile X-ray system
Z-0250-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number 40KWFXPLUS.889, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 1 unit
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Z-0269-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 1 unit
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
Z-0268-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 2 units
SM_40HF_BDC, Mobile X-ray system
Z-0286-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- SM_40HF_BDC, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 1 unit
RADPRO MOBILE, Mobile X-ray system
Z-0281-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- RADPRO MOBILE, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 24 units
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Z-0242-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
- Where it went
- US: CA, IL, and NJ
- How much
- 56 units
Model Number 40KWMOBILE3.899, Mobile X-ray system
Z-0253-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number 40KWMOBILE3.899, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 1 unit
Model Number 40KWFXPLUS.005, Mobile X-ray system
Z-0249-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number 40KWFXPLUS.005, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 12 units
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
Z-0274-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 6 units
Model Number 40KWFXPLUS.002, Mobile X-ray system
Z-0247-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number 40KWFXPLUS.002, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 8 units
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
Z-0267-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 5 units
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
Z-0262-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 8 units
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Z-0265-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 5 units
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Z-0260-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Product
- Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
- Where it went
- US: CA, IL, and NJ
- How much
- 14 units
Showing the 30 most recent of 53. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls