Sep 23, 2026
Z-3165-2026
NOxBOXi Nitric Oxide Delivery System.
NOXBOX LTD
- MRN
- 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 23, 2026
Z-3164-2026
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Produc…
Nuclein LLC
- NSU
- Class II
- Ongoing
Sep 23, 2026
Z-3163-2026
IV Sets with drip chambers
ICU Medical, Inc.
- FMG
- Class II
- Ongoing
Sep 23, 2026
Z-3162-2026
IV Sets with drip chambers
ICU Medical, Inc.
- FRN
- Class II
- Ongoing
Sep 23, 2026
Z-3161-2026
IV Sets with drip chambers
ICU Medical, Inc.
- ONB
- Class II
- Ongoing
Sep 23, 2026
Z-3160-2026
IV Sets with drip chambers
ICU Medical, Inc.
- FPA
- Class II
- Ongoing
Sep 23, 2026
Z-3159-2026
Oncology sets with drip chambers
ICU Medical, Inc.
- ONB
- Class II
- Ongoing
Sep 23, 2026
Z-3158-2026
Oncology sets with drip chambers
ICU Medical, Inc.
- FPA
- Class II
- Ongoing
Sep 23, 2026
Z-3157-2026
IV Non-Dedicated Gravity Administration Sets with drip chambers
ICU Medical, Inc.
- FMG
- Class II
- Ongoing
Sep 23, 2026
Z-3156-2026
Plum administration sets
ICU Medical, Inc.
- FPA
- Class II
- Ongoing
Sep 23, 2026
Z-3154-2026
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
AVID Medical, Inc.
- OES
- Class I
- Ongoing
Sep 23, 2026
Z-3153-2026
Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
AVID Medical, Inc.
- LRO
- Class I
- Ongoing
Sep 23, 2026
Z-3152-2026
Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
AVID Medical, Inc.
- OGD
- Class I
- Ongoing
Sep 23, 2026
Z-3151-2026
Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
AVID Medical, Inc.
- OGD
- Class I
- Ongoing
Sep 23, 2026
Z-3150-2026
Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optic…
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Sep 23, 2026
Z-3149-2026
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042…
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Sep 23, 2026
Z-3148-2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042…
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Sep 23, 2026
Z-3147-2026
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Bayer Medical Care, Inc.
- DXT
- Class II
- Ongoing
Sep 23, 2026
Z-3146-2026
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Maquet Cardiopulmonary Gmbh
- DWF
- Class II
- Ongoing
Sep 23, 2026
Z-3145-2026
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Maquet Cardiopulmonary Gmbh
- DWF
- Class II
- Ongoing
Sep 23, 2026
Z-3144-2026
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Maquet Cardiopulmonary Gmbh
- DWF
- Class II
- Ongoing
Sep 23, 2026
Z-3143-2026
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product C…
GE Medical Systems Information Technologies Inc
- DQK
- Class II
- Ongoing
Sep 23, 2026
Z-3142-2026
Philips PIC iX Essentials REF:867093
Philips North America
- MHX
- Class II
- Ongoing
Sep 23, 2026
Z-3141-2026
Philips Patient Information Center iX REF:866389
Philips North America
- MHX
- Class II
- Ongoing
Sep 23, 2026
Z-3137-2026
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Medline Industries, LP
- LRO
- Class II
- Ongoing