Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-03-01FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
- 2023-03-01FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
- 2023-03-01FDA-DeviceHologic, Inc.Class IIHologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
- 2023-03-01FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old) and adult serum, EDTA plasma, or lithium heparin. Siemens Material Number (SMN): 10720831
Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2 testing, regardless of whether both tests are performed on the same sample
- 2023-03-01FDA-DeviceDraeger Medical, Inc.Class INovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
- 2023-03-01FDA-DeviceDraeger Medical, Inc.Class INovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
- 2023-02-22FDA-DeviceSiemens Medical Solutions USA, Inc.Class IISIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
- 2023-02-22FDA-DeviceSiemens Medical Solutions USA, Inc.Class IISIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
- 2023-02-22FDA-DeviceSiemens Medical Solutions USA, Inc.Class IISIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
- 2023-02-22FDA-DeviceConformis, Inc.Class IIiTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.
- 2023-02-22FDA-DeviceOlympus Corporation of the AmericasClass IIEVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
- 2023-02-22FDA-DeviceAccess Vascular, IncClass IIHydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
- 2023-02-22FDA-DeviceAccess Vascular, IncClass IIHydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
- 2023-02-22FDA-DeviceAccess Vascular, IncClass IIHydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number SPEC0177; e) CENTURION MEDICAL PRODUCTS LUMBAR PUNCTURE KIT, Reorder Number PT235A
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY, Reorder Number CIT3345
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT12060; e) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT14705; f) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT17190; g) CENTUR
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- 2023-02-22FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IISurgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
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