Oct 7, 2026
Z-3321-2026
Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Percussionaire Corporation
- NHJ
- 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
Oct 7, 2026
Z-3320-2026
In-Line Valve, Product Number: P5-TEE
Percussionaire Corporation
- MOD
- Class II
- Ongoing
Oct 7, 2026
Z-3319-2026
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In…
Percussionaire Corporation
- NHJ
- Class II
- Ongoing
Oct 7, 2026
Z-3318-2026
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T),…
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3317-2026
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3316-2026
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3315-2026
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3314-2026
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1.…
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3313-2026
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3312-2026
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3311-2026
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 7821…
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3310-2026
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 78…
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3309-2026
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3308-2026
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5…
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3307-2026
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
Philips North America
- LNH
- Class II
- Ongoing
Oct 7, 2026
Z-3306-2026
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
NOXBOX LTD
- MRN
- Class II
- Ongoing
Oct 7, 2026
Z-3305-2026
Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CA…
Merit Medical Systems, Inc.
- KRD
- Class II
- Ongoing
Oct 7, 2026
Z-3304-2026
PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a…
Heraeus Medical GmbH (Dental Division)
- LOD
- Class II
- Ongoing
Oct 7, 2026
Z-3303-2026
PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled in…
Heraeus Medical GmbH (Dental Division)
- MBB
- Class II
- Ongoing
Oct 7, 2026
Z-3302-2026
PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into…
Heraeus Medical GmbH (Dental Division)
- MBB
- Class II
- Ongoing
Oct 7, 2026
Z-3301-2026
PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a…
Heraeus Medical GmbH (Dental Division)
- LOD
- Class II
- Ongoing
Oct 7, 2026
Z-3300-2026
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Olympus Corporation of the Americas
- HIH
- Class II
- Ongoing
Oct 7, 2026
Z-3299-2026
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Olympus Corporation of the Americas
- HIH
- Class II
- Ongoing
Oct 7, 2026
Z-3298-2026
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Cardinal Health 200, LLC
- OJF
- Class II
- Ongoing
Oct 7, 2026
Z-3297-2026
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW…
Cardinal Health 200, LLC
- OHD
- Class II
- Ongoing