Open, ClassifiedPosted May 30, 2025·Initiated Jun 18, 2024
FoundationOne Companion Diagnostic (F1CDx)
Reason: Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Root cause: Software design
Recalling firm: Foundation Medicine, Inc.Type: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemDistribution: US Nationwide distribution in the state of MI.Recall #Z-1890-2025
Open, ClassifiedPosted May 30, 2025·Initiated Feb 15, 2023
FoundationOne Companion Diagnostic (F1CDx)
Reason: An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Root cause: Software design
Recalling firm: Foundation Medicine, Inc.Type: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemDistribution: US Nationwide distribution in the state of WI.Recall #Z-1891-2025
Open, ClassifiedPosted May 30, 2025·Initiated May 1, 2025
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Reason: During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
Root cause: Process design
Recalling firm: Civco Medical Instruments Co. Inc.Type: Transducer, Ultrasonic, DiagnosticDistribution: OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and DenmarkRecall #Z-1892-2025
Open, ClassifiedPosted May 29, 2025·Initiated May 2, 2025
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Root cause: Package design/selection
Recalling firm: Cardinal Health 200, LLCType: Catheter, Umbilical ArteryDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.Recall #Z-1870-2025 Open, ClassifiedPosted May 29, 2025·Initiated May 2, 2025
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Root cause: Package design/selection
Recalling firm: Cardinal Health 200, LLCType: Catheter, Umbilical ArteryDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.Recall #Z-1871-2025 Open, ClassifiedPosted May 29, 2025·Initiated May 2, 2025
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Root cause: Package design/selection
Recalling firm: Cardinal Health 200, LLCType: Catheter, Umbilical ArteryDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.Recall #Z-1872-2025 Open, ClassifiedPosted May 29, 2025·Initiated May 2, 2025
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Root cause: Package design/selection
Recalling firm: Cardinal Health 200, LLCType: Catheter, Umbilical ArteryDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.Recall #Z-1873-2025 Open, ClassifiedPosted May 29, 2025·Initiated May 2, 2025
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Root cause: Package design/selection
Recalling firm: Cardinal Health 200, LLCType: Catheter, Umbilical ArteryDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.Recall #Z-1874-2025 Open, ClassifiedPosted May 29, 2025·Initiated May 2, 2025
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Root cause: Package design/selection
Recalling firm: Cardinal Health 200, LLCType: Catheter, Umbilical ArteryDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.Recall #Z-1875-2025 Open, ClassifiedPosted May 29, 2025·Initiated Apr 14, 2025
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Reason: Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
Root cause: Process control
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: C-Reactive Protein, Antigen, Antiserum, And ControlDistribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CO, FL, GA, ID, IL, IN, KS, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI, WV & WY and the countries of Canada, Chile, Colombia, France, India, Italy, Mexico & Singapore.Recall #Z-1876-2025
Open, ClassifiedPosted May 29, 2025·Initiated Apr 30, 2025
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Reason: Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Root cause: Under Investigation by firm
Recalling firm: BioFire Diagnostics, LLCType: Respiratory Virus Panel Nucleic Acid Assay SystemDistribution: International distribution in the country of Singapore.Recall #Z-1877-2025
Open, ClassifiedPosted May 29, 2025·Initiated Sep 1, 2023
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M.
b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M.
Component. of ELEOS LIMB SALVAGE SYSTEM
Reason: Potential for breach of Tyvek seals.
Root cause: Packaging change control
Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.Recall #Z-1879-2025
Open, ClassifiedPosted May 29, 2025·Initiated Sep 1, 2023
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M.
Component of ELEOS LIMB SALVAGE SYSTEM
Reason: Potential for breach of Tyvek seals.
Root cause: Packaging change control
Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.Recall #Z-1880-2025
Open, ClassifiedPosted May 29, 2025·Initiated Sep 1, 2023
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M.
Component of ELEOS LIMB SALVAGE SYSTEM
Reason: Potential for breach of Tyvek seals.
Root cause: Packaging change control
Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.Recall #Z-1881-2025
Open, ClassifiedPosted May 29, 2025·Initiated Sep 1, 2023
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M.
Component of ELEOS LIMB SALVAGE SYSTEM
Reason: Potential for breach of Tyvek seals.
Root cause: Packaging change control
Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.Recall #Z-1882-2025
Open, ClassifiedPosted May 29, 2025·Initiated Sep 1, 2023
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M.
Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Reason: Potential for breach of Tyvek seals.
Root cause: Packaging change control
Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedDistribution: Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.Recall #Z-1883-2025
Open, ClassifiedPosted May 29, 2025·Initiated Sep 1, 2023
Male-Female Midsection with the following sizes and model numbers.
a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E
b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E
c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E
d. Male-Female Midsection, 70mm, 1 EACH; Model Number:
e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E
f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E
g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E
Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Reason: Potential for breach of Tyvek seals.
Root cause: Packaging change control
Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.Recall #Z-1884-2025
Open, ClassifiedPosted May 28, 2025·Initiated Apr 14, 2025
Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266
UDI code: +D7457071SRG02660/$$76254798/16D20250219V
The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour.
The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.
Reason: Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Root cause: Process control
Recalling firm: Prismatik Dentalcraft, Inc.Type: Accessories, Implant, Dental, EndosseousDistribution: U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.Recall #Z-1856-2025
Open, ClassifiedPosted May 28, 2025·Initiated Sep 22, 2024
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E.
Component of ELEOS Limb Salvage System
Reason: Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Root cause: Nonconforming Material/Component
Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.Recall #Z-1857-2025
Open, ClassifiedPosted May 28, 2025·Initiated Apr 22, 2025
Brand Name: Catalyst+
Product Name: C4D software used in conjunction with
Catalyst (SP001-0025),
Catalyst HD (SP001-0026),
Catalyst PT (SP001-0027),
Catalyst X4 (SP002-0035),
Catalyst+ (SP003-0001),
Catalyst+ HD (SP003-0002),
Catalyst+ PT (SP003-0008),
Catalyst+ X4, (SPOO3-0009)
Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser
Component: Not a component
Reason: Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Root cause: Software design
Recalling firm: C-RAD POSITIONING ABType: Accelerator, Linear, MedicalDistribution: Worldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA, NC, IL, AR, NC and the countries of Germany, Italy, Uzbekistan, South Korea, Vietnam, Austria, Australia, China, Estonia, Belgium, Uzbekistan.Recall #Z-1858-2025