Open, ClassifiedPosted Mar 31, 2025·Initiated Feb 28, 2025
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Reason: Potential for the gold unlock button to separate from the inserter.
Root cause: Device Design
Recalling firm: Stryker SpineType: Intervertebral Fusion Device With Integrated Fixation, LumbarDistribution: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT.
International: Canada.Recall #Z-1488-2025
Open, ClassifiedPosted Mar 31, 2025·Initiated Feb 28, 2025
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Reason: Potential for the gold unlock button to separate from the inserter.
Root cause: Device Design
Recalling firm: Stryker SpineType: Intervertebral Fusion Device With Integrated Fixation, LumbarDistribution: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT.
International: Canada.Recall #Z-1489-2025
Open, ClassifiedPosted Mar 31, 2025·Initiated Feb 28, 2025
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Reason: Potential for the gold unlock button to separate from the inserter.
Root cause: Device Design
Recalling firm: Stryker SpineType: Intervertebral Fusion Device With Integrated Fixation, LumbarDistribution: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT.
International: Canada.Recall #Z-1490-2025
Open, ClassifiedPosted Mar 31, 2025·Initiated Feb 28, 2025
Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Reason: Potential for the gold unlock button to separate from the inserter.
Root cause: Device Design
Recalling firm: Stryker SpineType: Intervertebral Fusion Device With Integrated Fixation, LumbarDistribution: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT.
International: Canada.Recall #Z-1491-2025
Open, ClassifiedPosted Mar 31, 2025·Initiated Mar 3, 2025
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Reason: During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
Root cause: Software design
Recalling firm: Terumo Cardiovascular Systems CorporationType: Monitor, Blood-Gas, On-Line, Cardiopulmonary BypassDistribution: US: IL, TX, NY, MI, FL, NV, and Australia, New ZealandRecall #Z-1492-2025
Open, ClassifiedPosted Mar 31, 2025·Initiated Feb 28, 2025
Phoroptor VRx Digital Refraction System
Model Numbers: 16241
Reason: The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Root cause: Process control
Recalling firm: Reichert, Inc.Type: Refractor, Manual, Non-Powered, Including PhoropterDistribution: Domestic: Nationwide Distribution.
International: Austria, Bolivia, Canada, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Morocco, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, Slovakia, Switzerland, Thailand, United Arab Emirates, and United Kingdom.Recall #Z-1500-2025
Open, ClassifiedPosted Mar 31, 2025·Initiated Feb 28, 2025
Phoroptor VRx Digital Refraction System
Model Numbers: 16242
Reason: The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Root cause: Process control
Recalling firm: Reichert, Inc.Type: Refractor, Manual, Non-Powered, Including PhoropterDistribution: Domestic: Nationwide Distribution.
International: Austria, Bolivia, Canada, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Morocco, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, Slovakia, Switzerland, Thailand, United Arab Emirates, and United Kingdom.Recall #Z-1501-2025
Open, ClassifiedPosted Mar 31, 2025·Initiated Mar 6, 2025
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Reason: The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Root cause: Employee error
Recalling firm: Fisher DiagnosticsType: Test, Time, ProthrombinDistribution: US Distribution to: PA and OUS Foreign country of: United Arab Emirates.Recall #Z-1502-2025
Open, ClassifiedPosted Mar 31, 2025·Initiated Mar 6, 2025
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Reason: The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Root cause: Employee error
Recalling firm: Fisher DiagnosticsType: Test, Time, ProthrombinDistribution: US Distribution to: PA and OUS Foreign country of: United Arab Emirates.Recall #Z-1503-2025
Open, ClassifiedPosted Mar 31, 2025·Initiated Mar 12, 2025
Brand Name: QIAstat-Dx
Product Name: QIAstat-Dx Respiratory Panel Plus
Reference Number (REF): 691224
Software Version: n/a
Component: n/a
Reason: Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Root cause: Mixed-up of materials/components
Recalling firm: Qiagen Sciences LLCType: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsDistribution: US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.Recall #Z-1504-2025
Open, ClassifiedPosted Mar 28, 2025·Initiated Feb 25, 2025
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Polymer, Ear, Nose And Throat, Synthetic, AbsorbableDistribution: US Nationwide distribution.Recall #Z-1469-2025
Open, ClassifiedPosted Mar 28, 2025·Initiated Feb 25, 2025
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Polymer, Ear, Nose And Throat, Synthetic, AbsorbableDistribution: US Nationwide distribution.Recall #Z-1470-2025
Open, ClassifiedPosted Mar 28, 2025·Initiated Feb 25, 2025
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Polymer, Ear, Nose And Throat, Synthetic, AbsorbableDistribution: US Nationwide distribution.Recall #Z-1471-2025
Open, ClassifiedPosted Mar 28, 2025·Initiated Feb 25, 2025
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Polymer, Ear, Nose And Throat, Synthetic, AbsorbableDistribution: US Nationwide distribution.Recall #Z-1472-2025
Open, ClassifiedPosted Mar 28, 2025·Initiated Feb 25, 2025
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Polymer, Ear, Nose And Throat, Synthetic, AbsorbableDistribution: US Nationwide distribution.Recall #Z-1473-2025
Open, ClassifiedPosted Mar 28, 2025·Initiated Feb 25, 2025
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Polymer, Ear, Nose And Throat, Synthetic, AbsorbableDistribution: US Nationwide distribution.Recall #Z-1474-2025
Open, ClassifiedPosted Mar 28, 2025·Initiated Feb 25, 2025
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Polymer, Ear, Nose And Throat, Synthetic, AbsorbableDistribution: US Nationwide distribution.Recall #Z-1475-2025
Open, ClassifiedPosted Mar 28, 2025·Initiated Feb 25, 2025
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Polymer, Ear, Nose And Throat, Synthetic, AbsorbableDistribution: US Nationwide distribution.Recall #Z-1476-2025
Open, ClassifiedPosted Mar 28, 2025·Initiated Feb 25, 2025
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Polymer, Ear, Nose And Throat, Synthetic, AbsorbableDistribution: US Nationwide distribution.Recall #Z-1477-2025
Open, ClassifiedPosted Mar 28, 2025·Initiated Feb 25, 2025
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Polymer, Ear, Nose And Throat, Synthetic, AbsorbableDistribution: US Nationwide distribution.Recall #Z-1478-2025