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.
- 2022-09-28FDA-DeviceCAREFUSIONClass IIBD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
- 2022-09-28FDA-DeviceCAREFUSIONClass IIBD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
- 2022-09-28FDA-DeviceCAREFUSIONClass IIBD MaxGuard Extension Set, REF: ME1069
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
- 2022-09-28FDA-DeviceCAREFUSIONClass IIBD MaxGuard Extension Set with 4-way stopcock, REF: M4058
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
- 2022-09-21FDA-DeviceAlcor Scientific, Inc.Class IIiSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to the waste on the iSED Automated ESR Analyzer PN: 112-13-002
Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR Analyzer, there is a potential of a biohazard leak from the iSEDs Probe Tube
- 2022-09-21FDA-DeviceFUJIFILM Healthcare Americas CorporationClass IISurpria 64: Software Version V3.11, V3.22
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
- 2022-09-21FDA-DeviceFUJIFILM Healthcare Americas CorporationClass IISurpria: Software Version V3.11, V3.22
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
- 2022-09-21FDA-DeviceFUJIFILM Healthcare Americas CorporationClass IISCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
- 2022-09-21FDA-DeviceCarwild CorporationClass IIFABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
Sterility with new cotton source not validated
- 2022-09-21FDA-DeviceQiagen Sciences LLCClass IIQIAcube Connect MDx, Model No. 9003070
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
- 2022-09-21FDA-DeviceMallinckrodt, LLC.Class IIINOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007
The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.
- 2022-09-21FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIPinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
- 2022-09-21FDA-DeviceAniara Diagnostica LLCClass IIIBIOPHEN UFH Control Plasma
Incorrect product labeling was included in the package.
- 2022-09-21FDA-DeviceZap Surgical SystemsClass IIZAP-X Radiosurgery System
Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new treatment table offset values, leading to an incorrect position for the subsequent treatment isocenter.
- 2022-09-21FDA-DevicePolymer Technology Systems, Inc. dba PTS Diagnostics, Inc.Class IIIPTS Panels CHOL+GLU Test Strips (REF 1765)
Incorrect instructions for use were packaged into the final product.
- 2022-09-21FDA-DeviceMicrobiologics IncClass IIIHelix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Product not registered for use in the UK
- 2022-09-21FDA-DeviceIsopure CorpClass IIAcidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
- 2022-09-21FDA-DeviceTechnomed EuropeClass IIDisposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
- 2022-09-21FDA-DeviceSteris Corporation Hopkins FacilityClass IIIVerify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Product contains incorrect chemical indicators in packaging.
- 2022-09-21FDA-DeviceMako Surgical CorporationClass IIStryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
- 2022-09-21FDA-DeviceExactech, Inc.Class IIGXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- 2022-09-21FDA-DeviceExactech, Inc.Class IIGXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMEN
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- 2022-09-21FDA-DeviceExactech, Inc.Class IIGXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NO
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- 2022-09-21FDA-DeviceExactech, Inc.Class IIGXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- 2022-09-21FDA-DeviceExactech, Inc.Class IIGXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- 2022-09-21FDA-DeviceExactech, Inc.Class IIGXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, REF 130-36-53 d. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 4 CUPS, REF 130-36-54 e. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 5 CUPS, REF 130-36-55 f. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 3 CUPS, REF 136-32-53
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- 2022-09-21FDA-DeviceExactech, Inc.Class IIGXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE LINER 28MM SZ H, REF 130-28-28 e. ACUMATCH GXL 0 DEGREE LINER 28MM SZ J, REF 130-28-29 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ G, REF 130-32-27 g. ACUMATCH GXL 0 DEGREE LINER 32MM SZ H, REF 130-32-28 f. ACUMATCH GXL 0
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- 2022-09-21FDA-DeviceExactech, Inc.Class IIGXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d. ACUMATCH LINER 15 DEG 36MM ID, SIZE J, REF 132-36-09 e. ACUMATCH LINER 15 DEG 36MM ID, SIZE K, REF 132-36-10
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- 2022-09-21FDA-DeviceExactech, Inc.Class IIGXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- 2022-09-21FDA-DeviceExactech, Inc.Class IIGXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CO
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
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