Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-06-23FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Specific lots may have been manufactured with insufficient or incomplete welds.
- 2021-06-23FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
- 2021-06-23FDA-DeviceCovidien, LPClass IIHME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
- 2021-06-23FDA-DeviceCovidien, LPClass IIAdult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
- 2021-06-23FDA-DeviceCovidien, LPClass IIMechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
- 2021-06-23FDA-DeviceCovidien, LPClass IIElectrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
- 2021-06-23FDA-DeviceJohnson & Johnson Vision Care, Inc.Class IIACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
Potential that a limited number of individual contact lens packages have an incomplete packaging seal.
- 2021-06-23FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
- 2021-06-23FDA-DeviceCirculatory Technology Inc.Class IIThe Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
- 2021-06-23FDA-DeviceSkytron, Div. The KMW Group, IncClass IISkyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32
Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff
- 2021-06-23FDA-DeviceMedtronic VascularClass IAngiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use.
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
- 2021-06-23FDA-DeviceMedivators, Inc.Class IIDialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
- 2021-06-23FDA-DeviceRadiometer Medical ApSClass IIE3800 PC Units (spare parts)
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
- 2021-06-23FDA-DeviceRadiometer Medical ApSClass IIRadiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
- 2021-06-23FDA-DeviceRadiometer Medical ApSClass IIRadiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
- 2021-06-23FDA-DeviceAbbott Laboratories Inc. (St Jude Medical)Class IIWorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
- 2021-06-23FDA-DeviceAbbott Laboratories Inc. (St Jude Medical)Class IIv.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
- 2021-06-23FDA-DeviceAbbott Laboratories Inc. (St Jude Medical)Class IIv.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
- 2021-06-23FDA-DeviceAnodyne SurgicalClass IIHydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300
The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
- 2021-06-23FDA-DeviceCorin LtdClass IICorin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
- 2021-06-23FDA-DeviceCorin LtdClass IICorin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
- 2021-06-23FDA-DeviceWindstone Medical Packaging, Inc.Class IIAngio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz (250C 4 Clamp Towel 2.5 1 Drape Angio/FEM 87X124 W/2 V 1 Angio Tubing HP 10 W/ROT M/L 1 Needle RB 22 X 1.5 30 Sponge 4 X 4 X 12 Plain 10 Towel or Blue 1 Prep Ultrasound Gel Packet 1 Bowl Guidewire 80 Oz (2500C
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
- 2021-06-23FDA-DeviceWindstone Medical Packaging, Inc.Class IIAngio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22 2 Prep ChloraPrep One-Step 3 1 Dressing Transparent 4 X 4 1 Glove Perry 6.5 PF Steril 1 Bowl Fluid Containment W/Li 1 Cover backtable 50 X 90 Zon 1 Cup medicine 2 oz clear 2 Stopcock 3 way rot m/l/l 2 Needle RB
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
- 2021-06-16FDA-DeviceCooperSurgical, Inc.Class IICooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
- 2021-06-16FDA-DeviceBrainlab AGClass IIExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Display of potential patient movement might be delayed to the user for high dose treatments.
- 2021-06-16FDA-DeviceDePuy Orthopaedics, Inc.Class IIDePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
- 2021-06-16FDA-DeviceQuanta System, S.p.A.Class IIQuanta System Sterile Optical Laser Fiber, reusable
Product sterility is potentially compromised.
- 2021-06-16FDA-DeviceQuanta System, S.p.A.Class IIQuanta System Sterile Optical Laser Fiber, single use
Product sterility is potentially compromised.
- 2021-06-16FDA-DeviceQuanta System, S.p.A.Class IIOlympus Sterile Optical Laser Fiber, single use and reusable
Product sterility is potentially compromised.
- 2021-06-16FDA-DeviceMedline Industries IncClass IIMedline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
The devices may not meet the minimum required sterility assurance level.
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