Sep 9, 2026
Z-3064-2026
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 103010…
Johnson & Johnson Surgical Vision, Inc.
- LZP
- Class II
- 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 9, 2026
Z-3063-2026
Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Number: D…
Medline Industries, LP
- OIB
- Class II
- Ongoing
Sep 9, 2026
Z-3062-2026
Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM1881A; 3) TRIMA KIT, Model Number: DYNDB3077C
Medline Industries, LP
- OJH
- Class II
- Ongoing
Sep 9, 2026
Z-3061-2026
Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT…
Medline Industries, LP
- OJK
- Class II
- Ongoing
Sep 9, 2026
Z-3060-2026
Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B
Medline Industries, LP
- OHM
- Class II
- Ongoing
Sep 9, 2026
Z-3059-2026
Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F
Medline Industries, LP
- MLS
- Class II
- Ongoing
Sep 9, 2026
Z-3058-2026
Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE…
Medline Industries, LP
- OJU
- Class II
- Ongoing
Sep 9, 2026
Z-3057-2026
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A
Medline Industries, LP
- MCY
- Class II
- Ongoing
Sep 9, 2026
Z-3056-2026
Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number:…
Medline Industries, LP
- LRS
- Class II
- Ongoing
Sep 9, 2026
Z-3055-2026
Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295
Medline Industries, LP
- LRP
- Class II
- Ongoing
Sep 9, 2026
Z-3054-2026
Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-P…
Medline Industries, LP
- LRO
- Class II
- Ongoing
Sep 9, 2026
Z-3053-2026
Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C
Medline Industries, LP
- FTN
- Class II
- Ongoing
Sep 9, 2026
Z-3052-2026
Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D
Medline Industries, LP
- FDE
- Class II
- Ongoing
Sep 9, 2026
Z-3051-2026
Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A
Medline Industries, LP
- OIB
- Class II
- Ongoing
Sep 9, 2026
Z-3050-2026
Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4) DYNJ38145…
Medline Industries, LP
- OFF
- Class II
- Ongoing
Sep 9, 2026
Z-3049-2026
Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4)…
Medline Industries, LP
- OEZ
- Class II
- Ongoing
Sep 9, 2026
Z-3048-2026
Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A
Medline Industries, LP
- CAI
- Class II
- Ongoing
Sep 9, 2026
Z-3047-2026
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Diagnostica Stago, Inc.
- GGP
- Class II
- Ongoing
Sep 9, 2026
Z-3046-2026
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP1…
AVID Medical, Inc.
- OJH
- Class II
- Ongoing
Sep 9, 2026
Z-3045-2026
1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) L…
AVID Medical, Inc.
- OJG
- Class II
- Ongoing
Sep 9, 2026
Z-3044-2026
Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Num…
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Sep 9, 2026
Z-3043-2026
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Philips North America Llc
- JAK
- Class II
- Ongoing
Sep 9, 2026
Z-3042-2026
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Philips North America Llc
- JAK
- Class II
- Ongoing
Sep 9, 2026
Z-3041-2026
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Philips North America Llc
- JAK
- Class II
- Ongoing
Sep 9, 2026
Z-3040-2026
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Philips North America Llc
- JAK
- Class II
- Ongoing