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.
- 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.
- 2022-06-08FDA-DeviceBecton, Dickinson and Company, BD BiosciencesClass IIBD Anti-Kappa APC (Cat. No. 341098) 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.
- 2022-06-08FDA-DeviceAbbottClass IIFIRMap" Catheter, 60mm Basket
Incorrect product labeling.
- 2022-06-08FDA-DeviceXVIVO PERFUSION ABClass IIXVIVO Organ Chamber REF 19020
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
- 2022-06-08FDA-DeviceIntuitive Surgical, Inc.Class IIDAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
- 2022-06-08FDA-DeviceIntuitive Surgical, Inc.Class IIVESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
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