Oct 30, 2026
Z-0325-2027
CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010
Artivion, Inc
- DXZ
- Class II
- Open, Classified
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Oct 30, 2026
Z-0324-2027
VeriSeq Onsite Server V2 REF: 20047000
Illumina, Inc.
- PFF
- Class II
- Open, Classified
Oct 30, 2026
Z-0323-2027
Illumina DRAGEN Server for NextSeq 550Dx REF: 20086130,
Illumina, Inc.
- PFF
- Class II
- Open, Classified
Oct 30, 2026
Z-0322-2027
NovaSeq 6000Dx Instrument REF: 20068232, FOR IN VITRO DIAGNOSTIC USE
Illumina, Inc.
- PFF
- Class II
- Open, Classified
Oct 30, 2026
Z-0321-2027
MiSeq Dx Instrument REF: DX-410-1001 / 15036706, FOR IN VITRO DIAGNOSTIC USE
Illumina, Inc.
- PFF
- Class II
- Open, Classified
Oct 30, 2026
Z-0320-2027
Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USE
Illumina, Inc.
- PFF
- Class II
- Open, Classified
Oct 30, 2026
Z-0319-2027
Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011
NATUS MEDICAL INCORPORATED
- MNR
- Class II
- Open, Classified
Oct 30, 2026
Z-0318-2027
EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106
Smith & Nephew, Inc.
- HRS
- Class II
- Open, Classified
Oct 30, 2026
Z-0317-2027
Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
Accriva Diagnostics, Inc.
- JPA
- Class II
- Open, Classified
Oct 30, 2026
Z-0316-2027
Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911,…
Tandem Diabetes Care, Inc.
- QFG
- Class II
- Open, Classified
Oct 28, 2026
Z-0283-2027
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Oct 28, 2026
Z-0282-2027
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Oct 28, 2026
Z-0281-2027
MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B.
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0280-2027
MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0279-2027
MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0278-2027
MEDLINE medical convenience kits labeled as: (list truncated)
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0277-2027
MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M;…
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0276-2027
MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N; 2) NYGH-DELIVERY PACK-LF, Medline Kit Number/S…
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0275-2027
MEDLINE medical convenience kits labeled as (list truncated)
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0274-2027
MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R; 2) MAJOR, Medline Kit Number/SKUDYNJ904851I; 3) ABDOMIN…
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0273-2027
MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0272-2027
MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0271-2027
MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0270-2027
MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106
Medline Industries, LP
- PUI
- Class II
- Ongoing
Oct 28, 2026
Z-0269-2027
MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101
Medline Industries, LP
- PUI
- Class II
- Ongoing