Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IISedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number 40KWMOBILE3.899, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number 40KWFXPLUS-710CW.007, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number 40KWFXPLUS-710CW, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number 40KWFXPLUS.889, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number 40KWFXPLUS.005, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number 40KWFXPLUS.004, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number 40KWFXPLUS.002, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number 40KWFXPLUS, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIFollow Sedecal X-ray cleaning instructions carefully
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIFollow Sedecal X-ray cleaning instructions carefully
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIFollow cleaning instructions for Sedecal X-ray equipment
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IISedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
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.
- 2025-10-29FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIZenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
- 2025-10-29FDA-DeviceBecton Dickinson & Co.Class IIBD 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.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-10-29FDA-DeviceBecton Dickinson & Co.Class IIBD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-10-29FDA-DeviceBecton Dickinson & Co.Class IIBD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-10-29FDA-DeviceBecton Dickinson & Co.Class IIBD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-10-29FDA-DeviceBecton Dickinson & Co.Class IIBD 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 Instrument, Catalog Number: 44229609.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-10-29FDA-DeviceBecton Dickinson & Co.Class IIBD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
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