Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM;
Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
Reason: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Root cause: Process design
Recalling firm: D.O.R.C. Dutch Opthalmic Research Center Intl B.V.Type: Instrument, Vitreous Aspiration And Cutting, Ac-PoweredDistribution: Worldwide - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CZECHIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, IRELAND, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, TURKEY.Recall #Z-2323-2026
Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM;
Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;
Reason: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Root cause: Process design
Recalling firm: D.O.R.C. Dutch Opthalmic Research Center Intl B.V.Type: Instrument, Vitreous Aspiration And Cutting, Ac-PoweredDistribution: Worldwide - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CZECHIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, IRELAND, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, TURKEY.Recall #Z-2324-2026
Open, ClassifiedPosted Jun 5, 2026·Initiated May 1, 2026
Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm
Model/Catalog Number: CND0830
Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Root cause: Component design/selection
Recalling firm: INSPIREMD IncType: Stent, CarotidDistribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.Recall #Z-2325-2026
Open, ClassifiedPosted Jun 5, 2026·Initiated May 1, 2026
Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm
Model/Catalog Number: CND0840
Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Root cause: Component design/selection
Recalling firm: INSPIREMD IncType: Stent, CarotidDistribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.Recall #Z-2326-2026
Open, ClassifiedPosted Jun 5, 2026·Initiated May 1, 2026
CGuard Prime Carotid Stent System, 135cm, 9mx30mm
Model/Catalog Number: CND0930
Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Root cause: Component design/selection
Recalling firm: INSPIREMD IncType: Stent, CarotidDistribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.Recall #Z-2327-2026
Open, ClassifiedPosted Jun 5, 2026·Initiated May 1, 2026
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm
Model/Catalog Number: CND0940
Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Root cause: Component design/selection
Recalling firm: INSPIREMD IncType: Stent, CarotidDistribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.Recall #Z-2328-2026
Open, ClassifiedPosted Jun 5, 2026·Initiated May 1, 2026
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm
Model/Catalog Number: CND1030
Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Root cause: Component design/selection
Recalling firm: INSPIREMD IncType: Stent, CarotidDistribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.Recall #Z-2329-2026
Open, ClassifiedPosted Jun 5, 2026·Initiated May 1, 2026
CGuard Prime Carotid Stent System, 135cm, 10mmx40mm
Model/Catalog Number: CND1040
Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Root cause: Component design/selection
Recalling firm: INSPIREMD IncType: Stent, CarotidDistribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.Recall #Z-2330-2026
Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 13, 2026
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS
Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS
Model/Catalog Number: 1023780
Software Version: N/A
Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes.
The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access.
Component: N/A
Reason: Due to incorrect incubation process being performed on product.
Root cause: Under Investigation by firm
Recalling firm: HF Acquisition Co LLCType: Indicator, Biological Sterilization ProcessDistribution: U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, and WI.Recall #Z-2331-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 13, 2026
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS
Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS
Model/Catalog Number: 1023770
Software Version: N/A
Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes.
The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access.
Component: N/A
Reason: Due to incorrect incubation process being performed on product.
Root cause: Under Investigation by firm
Recalling firm: HF Acquisition Co LLCType: Indicator, Biological Sterilization ProcessDistribution: U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, and WI.Recall #Z-2332-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Brand Name: CORFLO
Product Name: CORFLO* Safety PEG Kit
Model/Catalog Number: 30-4320
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2333-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Brand Name: CORFLO
Product Name: CORFLO Safety PEG Kit
Model/Catalog Number: 30-5320
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2334-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: CORFLO* Safety PEG Kit
Model/Catalog Number: 30-6312
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2335-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: CORFLO* Safety PEG Kit
Model/Catalog Number: 30-6316
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2336-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit Connector
Model/Catalog Number: 50-4320
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2337-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit Connector
Model/Catalog Number: 50-5320
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2338-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: CORFLO* Safety PEG Kit with ENFit Connector
Model/Catalog Number: 50-6312
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2339-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: CORFLO Safety PEG Kit with ENFit Connector
Model/Catalog Number: 50-6316
Product Description: Feeding Tube Kit
Component: No
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2340-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW
Model/Catalog Number: 7170-14
Product Description: Feeding Tube Kit
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2341-2026 Open, ClassifiedPosted Jun 5, 2026·Initiated Apr 30, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW
Model/Catalog Number: 7170-20
Product Description: Feeding Tube Kit
Component: No
Reason: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Root cause: Material/Component Contamination
Recalling firm: Avanos Medical, Inc.Type: Tubes, Gastrointestinal (And Accessories)Distribution: US Nationwide distribution.Recall #Z-2342-2026