Open, ClassifiedPosted Sep 24, 2024·Initiated Sep 11, 2024
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Reason: Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.
Root cause: Under Investigation by firm
Recalling firm: Waldemar Link GmbH & Co. KG (Corp. Hq.)Type: Orthopedic Manual Surgical InstrumentDistribution: US Nationwide distribution in the states of FL, KS, MI, NJ, VA.Recall #Z-3245-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 1, 2024
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria.
Catalog Number: 443624
Reason: Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: System, Test, Automated, Antimicrobial Susceptibility, Short IncubationDistribution: Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic Ecuador, Egypt, El Salvador, Ethiopia, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal
Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore,
South Africa, South Korea, Spain, Sri Lanka, Switzerland, Syrian Arab, Republic Taiwan, Tanzania, United Republic of Thailand, Timor-Leste, Trinidad And Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, Vietnam, Zambia, Zimbabwe.Recall #Z-3246-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 1, 2024
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria.
Catalog Number: 448100
Reason: Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: System, Test, Automated, Antimicrobial Susceptibility, Short IncubationDistribution: Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic Ecuador, Egypt, El Salvador, Ethiopia, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal
Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore,
South Africa, South Korea, Spain, Sri Lanka, Switzerland, Syrian Arab, Republic Taiwan, Tanzania, United Republic of Thailand, Timor-Leste, Trinidad And Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, Vietnam, Zambia, Zimbabwe.Recall #Z-3247-2024
Open, ClassifiedPosted Sep 23, 2024·Initiated Aug 29, 2024
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA
Reason: Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could result in urinary tract, respiratory, bloodstream infections; workers handling contaminated product/instruments also at risk
Root cause: Material/Component Contamination
Recalling firm: Microcare MedicalType: DetergentDistribution: Worldwide - US Nationwide distribution in the states of MN, GA, PA, WA, CO, NY, MD, CA, MI, NE, UT, OK, WI, NJ, IL, ME, CT, KS, TX, NC, TN, SC, MO and the countries of Canada.Recall #Z-3209-2024
Open, ClassifiedPosted Sep 23, 2024·Initiated Aug 23, 2024
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.
Reason: Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.
Root cause: Labeling Change Control
Recalling firm: Stryker SpineType: Intervertebral Fusion Device With Integrated Fixation, CervicalDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-3210-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Aug 9, 2024
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
Reason: GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.
Root cause: Process control
Recalling firm: Wipro GE Healthcare Private Ltd.Type: Warmer, Infant RadiantDistribution: US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.Recall #Z-3080-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Aug 9, 2024
GE Panda iRES Warmer, Model/Catalog Numbers:
1) M1112198-01045518;
2) M1112198-01045579;
3) M1112198-01047148;
4) M1112198-01047271;
5) M1112198-01048731;
6) M1112198-01048740;
7) M1112198-01052386;
8) M1112198-01054697;
9) M1112198-01068942;
10) M1112198-01084972;
11) M1112198-01090848;
12) M1112198-01093457;
13) M1112198-01117766;
14) M1112198-01139893;
15) M1112198-01156745;
16) M1112198-01167230;
17) M1112198-01177090;
18) M1112198-01183599;
19) M1112198-01185372;
20) M1112198-01193801;
21) M1112198-01200764;
22) M1112198-01245548;
23) M1112198-01253742;
24) M1112198-01274059.
Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
Reason: GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.
Root cause: Process control
Recalling firm: Wipro GE Healthcare Private Ltd.Type: Warmer, Infant RadiantDistribution: US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.Recall #Z-3081-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated May 31, 2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Reason: Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
Root cause: Other
Recalling firm: Smiths Medical ASD Inc.Type: Ventilator, Emergency, Powered (Resuscitator)Distribution: Worldwide distribution.Recall #Z-3090-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated May 31, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Reason: Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
Root cause: Other
Recalling firm: Smiths Medical ASD Inc.Type: Ventilator, Emergency, Powered (Resuscitator)Distribution: Worldwide distribution.Recall #Z-3091-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Aug 8, 2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reason: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Root cause: Software design
Recalling firm: Datascope Corp.Type: System, Balloon, Intra-Aortic And ControlDistribution: International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, ECUADOR, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDONESIA, IRELAND, INDIA, IRAQ, IRAN, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, LIBYA, MOROCCO, MYANMAR, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PALESTINE, PORTUGAL, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVAKIA, THAILAND, TURKEY, TAIWAN, UNITED KINGDOM, VIETNAM, YEMEN.Recall #Z-3134-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Aug 8, 2024
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reason: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Root cause: Software design
Recalling firm: Datascope Corp.Type: System, Balloon, Intra-Aortic And ControlDistribution: International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, ECUADOR, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDONESIA, IRELAND, INDIA, IRAQ, IRAN, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, LIBYA, MOROCCO, MYANMAR, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PALESTINE, PORTUGAL, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVAKIA, THAILAND, TURKEY, TAIWAN, UNITED KINGDOM, VIETNAM, YEMEN.Recall #Z-3135-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Aug 8, 2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reason: Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Root cause: Software design
Recalling firm: Datascope Corp.Type: System, Balloon, Intra-Aortic And ControlDistribution: International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, ECUADOR, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDONESIA, IRELAND, INDIA, IRAQ, IRAN, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, LIBYA, MOROCCO, MYANMAR, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PALESTINE, PORTUGAL, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVAKIA, THAILAND, TURKEY, TAIWAN, UNITED KINGDOM, VIETNAM, YEMEN.Recall #Z-3136-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Aug 8, 2024
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reason: Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Root cause: Software design
Recalling firm: Datascope Corp.Type: System, Balloon, Intra-Aortic And ControlDistribution: International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, ECUADOR, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDONESIA, IRELAND, INDIA, IRAQ, IRAN, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, LIBYA, MOROCCO, MYANMAR, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PALESTINE, PORTUGAL, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVAKIA, THAILAND, TURKEY, TAIWAN, UNITED KINGDOM, VIETNAM, YEMEN.Recall #Z-3137-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Aug 15, 2024
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma.
Catalog Number: 07190794190
Reason: Creatine Kinase (CK) Assay Abnormal calibrations on the cobas c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
Root cause: Under Investigation by firm
Recalling firm: Roche Diagnostics Operations, Inc.Type: Differential Rate Kinetic Method, Cpk Or IsoenzymesDistribution: US Nationwide distribution.Recall #Z-3187-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Jul 31, 2024
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Reason: During the manufacturing process the devices were laser-marked with the incorrect part number.
Root cause: Process control
Recalling firm: CooperSurgical, Inc.Type: Sound, UterineDistribution: Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.Recall #Z-3188-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Jul 31, 2024
Stainless Steel Sims Uterine Sound, Part Number 64-601
Reason: During the manufacturing process the devices were laser-marked with the incorrect part number.
Root cause: Process control
Recalling firm: CooperSurgical, Inc.Type: Sound, UterineDistribution: Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.Recall #Z-3189-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Aug 12, 2024
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Reason: 7F sheath introducers labeled as 7.5F
Root cause: Labeling mix-ups
Recalling firm: Merit Medical Systems, Inc.Type: Dilator, Vessel, For Percutaneous CatheterizationDistribution: Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.Recall #Z-3190-2024 Open, ClassifiedPosted Sep 20, 2024·Initiated Aug 12, 2024
Custom Procedure Kit, REF: K12T-11077
Reason: 7F sheath introducers labeled as 7.5F
Root cause: Labeling mix-ups
Recalling firm: Merit Medical Systems, Inc.Type: Angiography/Angioplasty KitDistribution: Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.Recall #Z-3191-2024 Open, ClassifiedPosted Sep 20, 2024·Initiated Jul 2, 2024
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03;
Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X
Reason: Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
Root cause: Packaging change control
Recalling firm: Argon Medical Devices, IncType: Instrument, BiopsyDistribution: Worldwide - US Nationwide distribution including in the states of AZ, FL, OH, NY, MO, CO, IL, NC, CA, AK, PA, MN, ND, TX, SC, AR, WI, OK, TN, KS, UT, NJ, VA, MA, KY, IN, AL, DE, MT, NE, WV, NV, HI, OR, WA, NH, LA, CT, MI, GA, MD, ID, MS, IA, RI, NM, VT and the countries of ITA, TUN, ROU, LTU, BEL, GBR, CAN, TUR, POL, PAN, THA, PRT, TWN, AUT, NZL, AUS, BGR, MEX, CHE, NLD, PHL, PER, FRA, SGP, ZAF, CZE, EST, ESP, OMN, NPL, COL, PRI, ISR, JPN, KEN, BHR, ARE, CHN.Recall #Z-3192-2024
Open, ClassifiedPosted Sep 20, 2024·Initiated Sep 3, 2024
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.
(REF) Numbers:
(1) 782117
(2) 782143
Reason: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated.
movement.
Root cause: Under Investigation by firm
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark,
Ecuador, Egypt, Finland, France, Germany, Iceland, India, Indonesia, Iran, Iraq, Israel,
Italy, Japan, Jordan, Kuwait, Latvia, Maldives, Mauritius, Mexico, Morocco, Netherlands,
Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore,
Slovenia, South Africa, South Korea, Spain, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam.Recall #Z-3193-2024