Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas.
Order Number (GPN): G46602
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3259-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas.
Order Number (GPN): G46603
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3260-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias.
Order Number (GPN): G46603
Reason: Products expire prior to the expiration date printed on the product labeling
Root cause: Incorrect or no expiration date
Recalling firm: Cook Biotech, Inc.Type: Mesh, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,
China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, South Africa, United Kingdom.Recall #Z-3261-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 7, 2024
PT301US Airvo 3 Respiratory Support Device
with software version 1.2.0 and/or 1.5.1
The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
Reason: Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.
Root cause: Software change control
Recalling firm: Fisher & Paykel Healthcare, Ltd.Type: High Flow/High Velocity Humidified Oxygen Delivery DeviceDistribution: U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA and WA.
O.U.S.: Not providedRecall #Z-3262-2024
Open, ClassifiedPosted Sep 25, 2024·Initiated Aug 8, 2024
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Reason: On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
Root cause: Process control
Recalling firm: T.G. Eakin LimitedType: Protector, OstomyDistribution: US: KYRecall #Z-3263-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Jul 18, 2024
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Reason: During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Root cause: Process control
Recalling firm: Centinel Spine, Inc.Type: Prosthesis, Intervertebral DiscDistribution: US Nationwide distribution.Recall #Z-3212-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Jul 18, 2024
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
Reason: During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Root cause: Process control
Recalling firm: Centinel Spine, Inc.Type: Prosthesis, Intervertebral DiscDistribution: US Nationwide distribution.Recall #Z-3213-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 5, 2024
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Reason: GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.
Root cause: Device Design
Recalling firm: GE HealthcareType: System, Image Processing, RadiologicalDistribution: Worldwide distribution.Recall #Z-3214-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 15, 2024
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software.
ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
Reason: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Root cause: Software design
Recalling firm: Siemens Medical Solutions USA, Inc.Type: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US: MS, WA, TX, NJ, GA, PN, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM, AR, NC, PR, RI, WY, MD, FL, HI, AZ, SC, MO, OK, VA, ME, KS, MI, LA, IA, OH, SD, NH, KY, AL, OR, MA, GU.
OUS: Afghanistan, Albania, Algeria, Andorra, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Cameroon, Canada, Chile, China, Colombia, Congo, the Democratic Republic of the, Costa Rica, C¿te dIvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guinea, French Polynesia, Georgia, Germany, Greece, Guatemala, Guernsey, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein LI B, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Malta, Mexico, Moldova, Rep. of, Mongolia, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Reunion, Romania, Ruanda, Russian Federation, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe
Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 15, 2024
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Reason: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Root cause: Software design
Recalling firm: Siemens Medical Solutions USA, Inc.Type: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US: MS, WA, TX, NJ, GA, PN, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM, AR, NC, PR, RI, WY, MD, FL, HI, AZ, SC, MO, OK, VA, ME, KS, MI, LA, IA, OH, SD, NH, KY, AL, OR, MA, GU.
OUS: Afghanistan, Albania, Algeria, Andorra, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Cameroon, Canada, Chile, China, Colombia, Congo, the Democratic Republic of the, Costa Rica, C¿te dIvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guinea, French Polynesia, Georgia, Germany, Greece, Guatemala, Guernsey, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein LI B, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Malta, Mexico, Moldova, Rep. of, Mongolia, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Reunion, Romania, Ruanda, Russian Federation, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, Yemen, Zambia, ZimbabweRecall #Z-3216-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 15, 2024
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software.
ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
Reason: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Root cause: Software design
Recalling firm: Siemens Medical Solutions USA, Inc.Type: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US: MS, WA, TX, NJ, GA, PN, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM, AR, NC, PR, RI, WY, MD, FL, HI, AZ, SC, MO, OK, VA, ME, KS, MI, LA, IA, OH, SD, NH, KY, AL, OR, MA, GU.
OUS: Afghanistan, Albania, Algeria, Andorra, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Cameroon, Canada, Chile, China, Colombia, Congo, the Democratic Republic of the, Costa Rica, C¿te dIvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guinea, French Polynesia, Georgia, Germany, Greece, Guatemala, Guernsey, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein LI B, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Malta, Mexico, Moldova, Rep. of, Mongolia, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Reunion, Romania, Ruanda, Russian Federation, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe
Open, ClassifiedPosted Sep 24, 2024·Initiated Jul 23, 2024
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Root cause: Process design
Recalling firm: Karl Storz EndoscopyType: Kit, NephroscopeDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, Puerto Rico, Guam.Recall #Z-3218-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Jul 23, 2024
Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Root cause: Process design
Recalling firm: Karl Storz EndoscopyType: Kit, NephroscopeDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, Puerto Rico, Guam.Recall #Z-3219-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Jul 23, 2024
Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Root cause: Process design
Recalling firm: Karl Storz EndoscopyType: Kit, NephroscopeDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, Puerto Rico, Guam.Recall #Z-3220-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Jul 23, 2024
Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Root cause: Process design
Recalling firm: Karl Storz EndoscopyType: Kit, NephroscopeDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, Puerto Rico, Guam.Recall #Z-3221-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Jul 23, 2024
Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Root cause: Process design
Recalling firm: Karl Storz EndoscopyType: Kit, NephroscopeDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, Puerto Rico, Guam.Recall #Z-3222-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Jul 23, 2024
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Root cause: Process design
Recalling firm: Karl Storz EndoscopyType: Kit, NephroscopeDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, Puerto Rico, Guam.Recall #Z-3223-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Jul 23, 2024
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Root cause: Process design
Recalling firm: Karl Storz EndoscopyType: Kit, NephroscopeDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, Puerto Rico, Guam.Recall #Z-3224-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Jul 23, 2024
Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
Reason: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Root cause: Process design
Recalling firm: Karl Storz EndoscopyType: Kit, NephroscopeDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, Puerto Rico, Guam.Recall #Z-3225-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
PACEMAKER PACK, SLCV01J; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3226-2024