Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 16 of 63

Delta Med SpA

Class II Ongoing

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

Z-2305-2021 August 25, 2021 Viadana, N/A

Hitachi Healthcare Americas Corporation

Class II Ongoing

Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures

Reason: The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after s...

Z-2308-2021 August 25, 2021 Twinsburg, OH

Southwest Technologies Inc

Class II Ongoing

Stimulen Collagen Moisturizing Lotion, ST9555B

Reason: Dose audit failure after sterilization process

Z-2109-2021 July 28, 2021 Kansas City, MO

RanD S.r.l.

Class II Terminated

Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120

Reason: The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots...

Z-2048-2021 July 21, 2021 Medolla

RanD S.r.l.

Class II Terminated

Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.

Reason: The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots...

Z-2049-2021 July 21, 2021 Medolla

Spes Medica

Class II Terminated

Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.

Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

Z-1967-2021 July 7, 2021 Genoa, N/A

Spes Medica

Class II Terminated

SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number...

Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

Z-1968-2021 July 7, 2021 Genoa, N/A

Spes Medica

Class II Terminated

SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number...

Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

Z-1970-2021 July 7, 2021 Genoa, N/A

Spes Medica

Class II Terminated

Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.

Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

Z-1971-2021 July 7, 2021 Genoa, N/A

Spes Medica

Class II Terminated

Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.

Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

Z-1969-2021 July 7, 2021 Genoa, N/A

Adler MicroMed, Inc.

Class II Terminated

Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Shor...

Reason: Due to issue with product sterility. Sterilization service provider had falsified records.

Z-1901-2021 June 30, 2021 San Diego, CA

Covidien, LP

Class II Ongoing

Mechanical 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 circui...

Reason: 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...

Z-1867-2021 June 23, 2021 North Haven, CT

Medtronic Vascular

Class I Terminated

Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that f...

Reason: 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.

Z-1860-2021 June 23, 2021 Danvers, MA

Covidien, LP

Class II Ongoing

Adult-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 ...

Reason: 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...

Z-1868-2021 June 23, 2021 North Haven, CT

Covidien, LP

Class II Ongoing

HME 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...

Reason: 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...

Z-1869-2021 June 23, 2021 North Haven, CT

Covidien, LP

Class II Ongoing

Electrostatic 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...

Reason: 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...

Z-1866-2021 June 23, 2021 North Haven, CT

Omnia SRL

Class II Terminated

Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to ...

Reason: Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing f...

Z-1518-2021 May 5, 2021 Fidenza, N/A

Covidien Llc

Class II Terminated

Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thorac...

Reason: Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the ...

Z-1419-2021 April 21, 2021 Mansfield, MA

Getinge Group Logistics America, LLC

Class II Terminated

Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes a...

Reason: The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to...

Z-1124-2021 February 24, 2021 Wayne, NJ

Blue Ortho

Class II Terminated

Instructions For Use document of the GPS Trackers.

Reason: Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based ...

Z-0288-2021 November 4, 2020 Gieres, N/A

Biomet, Inc.

Class II Terminated

(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10...

Reason: Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data...

Z-0097-2021 October 21, 2020 Warsaw, IN

Medline Industries Inc

Class II Terminated

Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Managemen...

Reason: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

Z-0064-2021 October 14, 2020 Northfield, IL

Medline Industries Inc

Class II Terminated

Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good produ...

Reason: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

Z-0068-2021 October 14, 2020 Northfield, IL

Medline Industries Inc

Class II Terminated

Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Managemen...

Reason: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

Z-0067-2021 October 14, 2020 Northfield, IL

Medline Industries Inc

Class II Terminated

Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management fi...

Reason: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

Z-0063-2021 October 14, 2020 Northfield, IL