Class I
Ongoing
Reported Aug 19, 2026
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing sy...
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammat...
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Firm
- Spectra Medical Devices, Llc
- Recall began
- Jul 6, 2026
- Quantity
- TBD
- Codes
- Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, A...
- FDA IDs
- Z-2873-2026 / event 98777
Class II
Ongoing
Reported Aug 19, 2026
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may b...
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
U.S. Nationwide distribution in the states of GA and RI.
- Firm
- W L Gore & Associates, Inc.
- Recall began
- May 22, 2026
- Quantity
- 13 units
- Codes
- Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN101...
- FDA IDs
- Z-2914-2026 / event 99143
Class II
Ongoing
Reported Aug 19, 2026
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog...
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
US Nationwide. Canada.
- Firm
- Cardinal Health 200, LLC
- Recall began
- Jul 14, 2026
- Quantity
- 87182 kits
- Codes
- 1) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 2) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 3) 24-0726A,...
- FDA IDs
- Z-2945-2026 / event 99380
Class II
Ongoing
Reported Aug 19, 2026
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPAS...
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary,...
- Firm
- Covidien, LP
- Recall began
- Jun 24, 2026
- Quantity
- 135,875 total
- Codes
- BOX06614V4 UDI-DI 00199150037902 Lots 0233506453 0233506454 0233506455 0233506456 BOX07405V1 UDI-DI 00763000960186 Lot 0233617676 BOX01056V2 UDI-DI 00763000593711 Lot 0233484641 BO...
- FDA IDs
- Z-2919-2026 / event 99390
Class II
Ongoing
Reported Aug 19, 2026
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter int...
Due to an increase rate of balloon pinhole defects.
Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland...
- Firm
- MICROVENTION INC.
- Recall began
- Apr 30, 2026
- Quantity
- 5500 devices
- Codes
- Catalog Number: BOB-895-CN UDI codes: (01)00842429111062(11)250819(17)280731(10)0001218734 (01)00842429111062(11)250822(17)280731(10)0001222844 (01)00842429111062(11)250825(17)2807...
- FDA IDs
- Z-2912-2026 / event 98909
Class II
Ongoing
Reported Aug 19, 2026
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
US Nationwide. Canada.
- Firm
- Cardinal Health 200, LLC
- Recall began
- Jul 14, 2026
- Quantity
- 456 kits
- Codes
- 1) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot...
- FDA IDs
- Z-2943-2026 / event 99380
Class II
Ongoing
Reported Aug 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectivene...
US Nationwide distribution in the states and territories of Guam, Puerto Rico.
- Firm
- Medline Industries, LP
- Recall began
- Jun 30, 2026
- Quantity
- 31,728
- Codes
- UDI-DI (each) 00193489015242, UDI-DI (case) 20193489015246, Lot Numbers: All lots produced between 05/27/2025 and 04/10/2026
- FDA IDs
- Z-2926-2026 / event 99432
Class II
Ongoing
Reported Aug 19, 2026
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN3...
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
US Nationwide. Canada.
- Firm
- Cardinal Health 200, LLC
- Recall began
- Jul 14, 2026
- Quantity
- 52699 kits
- Codes
- 1) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 2) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 3) P...
- FDA IDs
- Z-2948-2026 / event 99380
Class II
Ongoing
Reported Aug 19, 2026
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Firmware issue potentially leading to loss of geometry movements.
Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, Fra...
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Recall began
- Jun 29, 2026
- Quantity
- 4,252 units
- Codes
- Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)0088...
- FDA IDs
- Z-2928-2026 / event 99378
Class II
Ongoing
Reported Aug 19, 2026
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial...
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Worldwide distribution - US Nationwide and the country of Canada.
- Firm
- Terumo Medical Corporation
- Recall began
- Jun 15, 2026
- Quantity
- 7,490 units
- Codes
- Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
- FDA IDs
- Z-2930-2026 / event 99285
Class II
Ongoing
Reported Aug 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectivene...
US Nationwide distribution in the states and territories of Guam, Puerto Rico.
- Firm
- Medline Industries, LP
- Recall began
- Jun 30, 2026
- Quantity
- 1,244 units
- Codes
- UDI-DI (each) 80080196314521, UDI-DI (case) 10080196314522, Lot Numbers: All lots produced between 10/27/2025 and 11/19/2025
- FDA IDs
- Z-2925-2026 / event 99432
Class II
Ongoing
Reported Aug 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectivene...
US Nationwide distribution in the states and territories of Guam, Puerto Rico.
- Firm
- Medline Industries, LP
- Recall began
- Jun 30, 2026
- Quantity
- 447,618 units
- Codes
- UDI-DI (each) 10888277652521, UDI-DI (case) 20888277652528, Lot Numbers: All lots produced between 05/13/2025 and 04/21/2026
- FDA IDs
- Z-2924-2026 / event 99432