Sep 30, 2026
Z-3194-2026
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
AVID Medical, Inc.
- LRO
- Class I
- Ongoing
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Sep 30, 2026
Z-3140-2026
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709,…
CooperSurgical, Inc.
- BZD
- Class I
- Ongoing
Sep 30, 2026
Z-3139-2026
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-27…
CooperSurgical, Inc.
- BZD
- Class I
- Ongoing
Sep 23, 2026
Z-3213-2026
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
PI CARDIA LTD
- SCZ
- Class II
- Ongoing
Sep 23, 2026
Z-3212-2026
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-…
ICU Medical, Inc.
- LHI
- Class II
- Ongoing
Sep 23, 2026
Z-3211-2026
Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20…
F & A Foundation
- JDR
- Class II
- Ongoing
Sep 23, 2026
Z-3210-2026
Convenience kits CATARACT PACK DYNJ59881A
Medline Industries, LP
- OJK
- Class II
- Ongoing
Sep 23, 2026
Z-3209-2026
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Medline Industries, LP
- LRO
- Class II
- Ongoing
Sep 23, 2026
Z-3208-2026
Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
Medline Industries, LP
- FDE
- Class II
- Ongoing
Sep 23, 2026
Z-3207-2026
Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
Medline Industries, LP
- OFT
- Class II
- Ongoing
Sep 23, 2026
Z-3206-2026
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (…
Howmedica Osteonics Corp.
- NPJ
- Class II
- Ongoing
Sep 23, 2026
Z-3205-2026
SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implan…
Howmedica Osteonics Corp.
- Class II
- Ongoing
Sep 23, 2026
Z-3204-2026
TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp.
- MEH
- Class II
- Ongoing
Sep 23, 2026
Z-3203-2026
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp.
- MBH
- Class II
- Ongoing
Sep 23, 2026
Z-3202-2026
BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopae…
Howmedica Osteonics Corp.
- LGE
- Class II
- Ongoing
Sep 23, 2026
Z-3201-2026
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL PO…
Howmedica Osteonics Corp.
- KWZ
- Class II
- Ongoing
Sep 23, 2026
Z-3200-2026
DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-…
Howmedica Osteonics Corp.
- KWS
- Class II
- Ongoing
Sep 23, 2026
Z-3199-2026
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm…
Howmedica Osteonics Corp.
- KWL
- Class II
- Ongoing
Sep 23, 2026
Z-3198-2026
TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethyle…
Howmedica Osteonics Corp.
- KRO
- Class II
- Ongoing
Sep 23, 2026
Z-3197-2026
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME…
Howmedica Osteonics Corp.
- JWH
- Class II
- Ongoing
Sep 23, 2026
Z-3196-2026
OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp.
- JDL
- Class II
- Ongoing
Sep 23, 2026
Z-3195-2026
AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp.
- JDC
- Class II
- Ongoing
Sep 23, 2026
Z-3193-2026
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Mirion Technologies (Capintec), Inc.
- IZD
- Class II
- Ongoing
Sep 23, 2026
Z-3192-2026
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) pa…
Datex-Ohmeda, Inc.
- BSZ
- Class II
- Ongoing
Sep 23, 2026
Z-3191-2026
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Datex-Ohmeda, Inc.
- BSZ
- Class II
- Ongoing