Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-07-01FDA-DeviceMevion Medical Systems, Inc.Class IIMEVION S250i, MEVION S250; Proton Radiation Treatment System
Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off
- 2020-07-01FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.
- 2020-07-01FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.
- 2020-07-01FDA-DeviceMerge Healthcare, Inc.Class IIMerge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal
An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.
- 2020-06-24FDA-DeviceDiasol, IncClass IIDIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Incorrect labeling of dialysate concentration for hemodialysis.
- 2020-06-24FDA-DeviceAbbott Gmbh & Co. KGClass IIAlinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
- 2020-06-24FDA-DeviceCarefusion 2200 IncClass IIMueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially causing the collet to not fully seat in the knife handle (Figure 2), inhibiting complete grip of the inserted knife blade possibly resulting in a loose blade.
- 2020-06-24FDA-DeviceLeica Microsystems, Inc.Class IILeica ARveo and M530 OH6 microscope systems.
Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
- 2020-06-24FDA-DeviceAngiodynamics, Inc.Class IIBioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Item Numbers H965750011 H965750031 H965750121 H965750131 H965750141 H965750151 H965750161 H965750171 H965750181 H965750191 H965750211 H965750221 H965
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
- 2020-06-24FDA-DeviceAngiodynamics, Inc.Class IIBioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Item Numbers H96560M01162101 H96560M0116291 H96560M0133531 H96560M0134211 H96560M0198811 H96560M0224741 H96560M0224751 H96560M0335621 H96560M0367041 H96560M0367051
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
- 2020-06-24FDA-DeviceAngiodynamics, Inc.Class IIBioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H96560M0125711 H96560M0133541 H96560M0354721 H96560M0367081 H96560M05019121 H96560M05019131 H96560M1220291 H96560M1303161 H96560M1303181 H96560M1318211 H96560M1408911 H96560M1429481 H96560M1803431 H96560M18157131 H96560M2208531 H96560M2208541 H96560M2500981 H96560
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
- 2020-06-24FDA-DeviceAngiodynamics, Inc.Class IIBioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161 H965460161-NP H965460171 H965460181 H965460221 H965460231 H965460241 H965460251 H965460261 H965460271 H965460281 H965460291 H965464601 H965464701 H965464701-NP H965464801 H965464901 Cat. No. 46-015 46-016 46-016
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
- 2020-06-24FDA-DeviceDefibtech, LLCClass IIDDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E2460DE DCF-E2460EN DCF-E2460FR DCF-E2460TH UDI 00815098020287, 00815098020317 Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
- 2020-06-24FDA-DeviceDefibtech, LLCClass IIDDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
- 2020-06-24FDA-DeviceDefibtech, LLCClass IIDDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
- 2020-06-24FDA-DeviceMedtronic Sofamor Danek USA IncClass IIMedtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
- 2020-06-24FDA-DeviceMedtronic Sofamor Danek USA IncClass IIMedtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
- 2020-06-24FDA-DeviceMedtronic Sofamor Danek USA IncClass IIExtremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
- 2020-06-24FDA-DeviceSiemens Medical Solutions USA, IncClass IIMAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
- 2020-06-24FDA-DeviceStryker GmbHClass IIStryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Seal integrity of the blister pack may be compromised and sterility cannot be assured
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