Sep 30, 2026
Z-3266-2026
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Medline Industries, LP
- FDE
- 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 30, 2026
Z-3265-2026
Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ4009…
Medline Industries, LP
- OGR
- Class II
- Ongoing
Sep 30, 2026
Z-3264-2026
PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressu…
Baxter Healthcare Corporation
- IOQ
- Class II
- Ongoing
Sep 30, 2026
Z-3263-2026
PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressu…
Baxter Healthcare Corporation
- IOQ
- Class II
- Ongoing
Sep 30, 2026
Z-3262-2026
PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-ba…
Baxter Healthcare Corporation
- IOQ
- Class II
- Ongoing
Sep 30, 2026
Z-3261-2026
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Sep 30, 2026
Z-3260-2026
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 II
- Ongoing
Sep 30, 2026
Z-3259-2026
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gown…
New York Embroidery Studio, Inc.
- OEA
- Class II
- Ongoing
Sep 30, 2026
Z-3258-2026
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
INTERVASCULAR, SAS
- DSY
- Class II
- Ongoing
Sep 30, 2026
Z-3257-2026
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERI…
Baxter Healthcare Corporation
- NHJ
- Class II
- Ongoing
Sep 30, 2026
Z-3256-2026
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
DeRoyal Industries Inc
- FLL
- Class II
- Ongoing
Sep 30, 2026
Z-3255-2026
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
Cardinal Health 200, LLC
- OWL
- Class II
- Ongoing
Sep 30, 2026
Z-3254-2026
Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catal…
Cardinal Health 200, LLC
- LRP
- Class II
- Ongoing
Sep 30, 2026
Z-3253-2026
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R
Criticare Technologies, Inc.
- MHX
- Class II
- Ongoing
Sep 30, 2026
Z-3251-2026
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 II
- Ongoing
Sep 30, 2026
Z-3250-2026
ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct moni…
Becton, Dickinson and Company
- MUD
- Class II
- Ongoing
Sep 30, 2026
Z-3249-2026
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Philips Ultrasound, LLC
- IYN
- Class II
- Ongoing
Sep 30, 2026
Z-3248-2026
Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
CooperVision, Inc.
- MVN
- Class II
- Ongoing
Sep 30, 2026
Z-3247-2026
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
Olympus Corporation of the Americas
- KNS
- Class II
- Ongoing
Sep 30, 2026
Z-3246-2026
Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
Olympus Corporation of the Americas
- KNS
- Class II
- Ongoing
Sep 30, 2026
Z-3245-2026
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
Olympus Corporation of the Americas
- KNS
- Class II
- Ongoing
Sep 30, 2026
Z-3244-2026
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
Olympus Corporation of the Americas
- KNS
- Class II
- Ongoing
Sep 30, 2026
Z-3243-2026
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781…
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3242-2026
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3241-2026
MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Philips North America Llc
- LNH
- Class II
- Ongoing