Sep 23, 2026
Z-3132-2026
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Nova Biomedical Corporation
- PZI
- 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 23, 2026
Z-3131-2026
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
Nova Biomedical Corporation
- PZI
- Class I
- Ongoing
Sep 23, 2026
Z-3130-2026
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
Nova Biomedical Corporation
- PZI
- Class I
- Ongoing
Sep 23, 2026
Z-3129-2026
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Nova Biomedical Corporation
- PZI
- Class I
- Ongoing
Sep 23, 2026
Z-3128-2026
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
Nova Biomedical Corporation
- PZI
- Class I
- Ongoing
Sep 23, 2026
Z-3127-2026
Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYN…
Medline Industries, LP
- OIB
- Class I
- Ongoing
Sep 23, 2026
Z-3126-2026
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
Medline Industries, LP
- MCY
- Class I
- Ongoing
Sep 23, 2026
Z-3125-2026
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
Medline Industries, LP
- LRS
- Class I
- Ongoing
Sep 23, 2026
Z-3124-2026
Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC…
Medline Industries, LP
- LRO
- Class I
- Ongoing
Sep 23, 2026
Z-3123-2026
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F
Medline Industries, LP
- OFF
- Class I
- Ongoing
Sep 23, 2026
Z-3122-2026
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REM…
Medline Industries, LP
- OEZ
- Class I
- Ongoing
Sep 23, 2026
Z-3121-2026
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
Medline Industries, LP
- CAI
- Class I
- Ongoing
Sep 23, 2026
Z-3108-2026
Halyard IV START KIT NON-STERILE REF: KRIV26-02
AVID Medical, Inc.
- LRO
- Class I
- Ongoing
Sep 23, 2026
Z-3080-2026
BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015…
BD SWITZERLAND SARL
- FPA
- Class I
- Ongoing
Sep 23, 2026
Z-2985-2026
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-Term Straight Dialys…
Bard Access Systems, Inc.
- MPB
- Class I
- Ongoing
Sep 23, 2026
Z-2984-2026
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short…
Bard Access Systems, Inc.
- MPB
- Class I
- Ongoing
Sep 16, 2026
Z-3138-2026
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Windstone Medical Packaging, Inc.
- KDD
- Class II
- Ongoing
Sep 16, 2026
Z-3136-2026
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Nipro Renal Soultions USA, Corporation
- KPO
- Class II
- Ongoing
Sep 16, 2026
Z-3135-2026
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Nipro Renal Soultions USA, Corporation
- KPO
- Class II
- Ongoing
Sep 16, 2026
Z-3134-2026
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Nipro Renal Soultions USA, Corporation
- KPO
- Class II
- Ongoing
Sep 16, 2026
Z-3133-2026
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Nipro Renal Soultions USA, Corporation
- KPO
- Class II
- Ongoing
Sep 16, 2026
Z-3120-2026
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0…
HeartSine Technologies Ltd
- MKJ
- Class II
- Ongoing
Sep 16, 2026
Z-3119-2026
Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureSt…
C.R. Bard Inc
- KNX
- Class II
- Ongoing
Sep 16, 2026
Z-3118-2026
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Fole…
C.R. Bard Inc
- KNX
- Class II
- Ongoing
Sep 16, 2026
Z-3117-2026
Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code:…
C.R. Bard Inc
- KOD
- Class II
- Ongoing