Open, ClassifiedPosted Jan 10, 2025·Initiated Nov 22, 2024
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Reason: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Root cause: Under Investigation by firm
Recalling firm: Cook Biotech, Inc.Type: Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)Distribution: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.Recall #Z-0832-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Nov 22, 2024
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Reason: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Root cause: Under Investigation by firm
Recalling firm: Cook Biotech, Inc.Type: Mesh, Surgical, Collagen, Diaphragmatic HerniaDistribution: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.Recall #Z-0833-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Nov 22, 2024
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Reason: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Root cause: Under Investigation by firm
Recalling firm: Cook Biotech, Inc.Type: Dura SubstituteDistribution: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.Recall #Z-0834-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Nov 13, 2024
Brand Name: Alcon
Product Name: Monarch III D Delivery Cartridge
Model/Catalog Number: 8065977763
Product Description: Monarch III D delivery cartridge
Lens Guide, Intraocular
Component: N/A
Reason: Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.
Root cause: Process design
Recalling firm: Alcon Research LLCType: Lens, Guide, IntraocularDistribution: US: AK AL AR AZ CA CO CT DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY
OUS: Russia, EgyptRecall #Z-0835-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 10, 2024
Idylla INSTRUMENT, IVD, REF P0010.
Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
Reason: False-positive MSI-H results generated by the Idylla MSI Test.
Root cause: Environmental control
Recalling firm: Biocartis NvType: Real Time Nucleic Acid Amplification SystemDistribution: US: AL, NJ, TX, OH, CARecall #Z-0836-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Reason: Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Root cause: Reprocessing Controls
Recalling firm: Karl Storz EndoscopyType: Instrument, Ent Manual SurgicalDistribution: US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT,
NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA
OUS: NoneRecall #Z-0837-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Nov 5, 2024
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Reason: Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.
Root cause: Device Design
Recalling firm: NOA Medical Industries IncType: Aid, TransferDistribution: US: GA, MI. MA, CARecall #Z-0838-2025
CompletedPosted Jan 10, 2025·Initiated Mar 14, 2022
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) Model # WC71,
2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
Reason: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: WorldwideRecall #Z-0839-2025
CompletedPosted Jan 10, 2025·Initiated Mar 14, 2022
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) Model # WC77,
2) Model # WC77D (Demo),
3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
Reason: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: WorldwideRecall #Z-0840-2025
CompletedPosted Jan 10, 2025·Initiated Mar 14, 2022
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Reason: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: WorldwideRecall #Z-0841-2025
CompletedPosted Jan 10, 2025·Initiated Mar 14, 2022
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) WC71V;
2) WC71V-DEMO;
3) WC71V-R;
used in conjunction with Warming Blankets and Mattresses, veterinary use.
Reason: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: WorldwideRecall #Z-0842-2025
CompletedPosted Jan 10, 2025·Initiated Mar 14, 2022
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models:
1) WC77V;
2) WC77V-DEMO;
3) WC77V-R;
used in conjunction with Warming Blankets and Mattresses, veterinary use.
Reason: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: WorldwideRecall #Z-0843-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 2, 2024
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
Reason: A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Root cause: Packaging
Recalling firm: Coloplast Manufacturing US, LLCType: Catheter, Retention Type, BalloonDistribution: US Nationwide. Canada.Recall #Z-0844-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 2, 2024
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
Reason: A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Root cause: Packaging
Recalling firm: Coloplast Manufacturing US, LLCType: Catheter, Retention Type, BalloonDistribution: US Nationwide. Canada.Recall #Z-0845-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200.
Indicated for use during Total Shoulder Arthroplasty.
Reason: The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.
Root cause: Device Design
Recalling firm: Tornier S.A.S.Type: Orthopedic Stereotaxic InstrumentDistribution: US: MN, KY, MD, MA, TX, AK, TX, ID; France, CanadaRecall #Z-0846-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0847-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM, POTTS SCISSORS, IS4000 REF 470001
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0848-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0849-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM, ROUND TIP SCISSORS, IS4000 REF 470007
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0850-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 REF 470033
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0851-2025