Medical device recalls
38750 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-06-15FDA-DeviceSiemens Medical Solutions USA, IncClass IISensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
- 2022-06-15FDA-DeviceCook IncorporatedClass IITornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
- 2022-06-15FDA-DeviceCook IncorporatedClass IINester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G52738 MWCE-18-7-6-NESTER-01 G47341 MWCE-18-3-3-NESTER-01 G47332 MWCE-18-7-4-NESTER G52
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
- 2022-06-15FDA-DeviceCook IncorporatedClass IIHilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
- 2022-06-15FDA-DeviceOakworks IncClass IIOakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
- 2022-06-15FDA-DeviceOakworks IncClass IIPX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
- 2022-06-15FDA-DeviceHowmedica Osteonics Corp.Class IITriathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
- 2022-06-15FDA-DeviceNew Standard Device IncClass II1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.
- 2022-06-15FDA-DeviceNorthgate Technologies, Inc.Class IIAUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Product labeled incorrectly.
- 2022-06-15FDA-DeviceKarl Storz EndoscopyClass IISTORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT
The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
- 2022-06-15FDA-DeviceGE Healthcare, LLCClass IICentricity PACS RA1000
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
- 2022-06-15FDA-DeviceGE Healthcare, LLCClass IICentricity Cardiology CA1000
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
- 2022-06-15FDA-DeviceGE Healthcare, LLCClass IICentricity Radiology RA600
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
- 2022-06-15FDA-DeviceGE Healthcare, LLCClass IICentricity Enterprise Web
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
- 2022-06-15FDA-DeviceGE Healthcare, LLCClass IICentricity Universal Viewer Zero Footprint Client
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
- 2022-06-15FDA-DeviceBSN Medical IncClass II(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximatel
The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
- 2022-06-15FDA-DeviceGE Healthcare, LLCClass IReplacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
- 2022-06-15FDA-DeviceGE Healthcare, LLCClass IBack up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
- 2022-06-15FDA-DeviceMedtronic IncClass IHeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
- 2022-06-08FDA-DeviceMicroPort Orthopedics Inc.Class IIPROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
- 2022-06-08FDA-DeviceMedtronic Xomed, Inc.Class IINIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Software anomaly was identified.
- 2022-06-08FDA-DeviceMedtronic Xomed, Inc.Class IINIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Software anomaly was identified.
- 2022-06-08FDA-DeviceDynex Technologies, Inc.Class IIDYNEX Agility, Agility Analyzer, Model No. 67000
Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.
- 2022-06-08FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
- 2022-06-08FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
- 2022-06-08FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
- 2022-06-08FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
- 2022-06-08FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
- 2022-06-08FDA-DeviceTornier, IncClass IIRatcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
- 2022-06-08FDA-DeviceBecton, Dickinson and Company, BD BiosciencesClass IIBD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
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