| Reported | Recall | Class | Product | Firm |
|---|
| 2026-07-01 | Z-2599-2026 | Class I | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP | Abiomed, Inc. |
| 2026-07-01 | Z-2600-2026 | Class I | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP | Abiomed, Inc. |
| 2026-07-01 | Z-2601-2026 | Class I | Abiomed Impella CP Set with SmartAssist | Abiomed, Inc. |
| 2026-07-01 | Z-2602-2026 | Class I | Abiomed Impella CP Set with SmartAssist | Abiomed, Inc. |
| 2026-06-24 | Z-2357-2026 | Class I | Giraffe Stand-alone Infant Resuscitation System | Datex-Ohmeda Inc |
| 2026-06-24 | Z-2358-2026 | Class I | Giraffe Warmer with Integrated Resuscitation System | Datex-Ohmeda Inc |
| 2026-06-24 | Z-2359-2026 | Class I | Panda Freestanding Warmer | Datex-Ohmeda Inc |
| 2026-06-24 | Z-2360-2026 | Class I | Automated Impella Controller | Abiomed, Inc. |
| 2026-06-24 | Z-2363-2026 | Class I | PARACENTESIS KIT | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2364-2026 | Class I | Description/REF: ACCESS TRAY/ASK-04001-SUH-S | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2365-2026 | Class I | Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2366-2026 | Class I | Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2367-2026 | Class I | Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2368-2026 | Class I | Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1 | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2369-2026 | Class I | Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2370-2026 | Class I | Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS… | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2371-2026 | Class I | Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1 | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2372-2026 | Class I | Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2373-2026 | Class I | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2374-2026 | Class I | Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2375-2026 | Class I | Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2 | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2376-2026 | Class I | Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2377-2026 | Class I | Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA… | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2378-2026 | Class I | Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2379-2026 | Class I | Description/REF: PI JACC KIT: 2L 5 | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2380-2026 | Class I | Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2381-2026 | Class I | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2382-2026 | Class I | Description/REF: DRAINAGE KIT/AK-01600 | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2383-2026 | Class I | Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2384-2026 | Class I | Description/REF: ACCESS TRAY/ASK-04001-JHH | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2385-2026 | Class I | Description/REF: ACCESS TRAY/GU-04020 | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2386-2026 | Class I | Description/REF: PARACENTESIS KIT/ASK-00376-JHH | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2387-2026 | Class I | Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2388-2026 | Class I | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2389-2026 | Class I | Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2390-2026 | Class I | Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2391-2026 | Class I | Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2392-2026 | Class I | Description/REF: ACCESS TRAY/ASK-04001-MC3 | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2393-2026 | Class I | Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2394-2026 | Class I | Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2395-2026 | Class I | Description/REF: PICC ACCESS TRAY/ASK-04001-CG1 | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2396-2026 | Class I | Description/REF: CVC KIT: 16 GA X 8IN/AK-04210 | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2397-2026 | Class I | Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A | ARROW INTERNATIONAL, LLC |
| 2026-06-24 | Z-2411-2026 | Class II | Philips MultiDiagnost Eleva with the following Model Numbers: Model #… | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-06-24 | Z-2412-2026 | Class II | Philips Allura Xper with the following Model Numbers: Model # 722001… | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 2026-06-24 | Z-2414-2026 | Class II | Medline EBSI Kit EBSI1534 | Medline Industries, LP |
| 2026-06-24 | Z-2415-2026 | Class II | Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716 | Medline Industries, LP |
| 2026-06-24 | Z-2416-2026 | Class II | BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A | Medline Industries, LP |
| 2026-06-24 | Z-2417-2026 | Class II | MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D… | Medline Industries, LP |
| 2026-06-24 | Z-2418-2026 | Class II | Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y… | Medline Industries, LP |
| 2026-06-24 | Z-2419-2026 | Class II | Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525… | Medline Industries, LP |
| 2026-06-24 | Z-2420-2026 | Class II | Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L | Medline Industries, LP |
| 2026-06-24 | Z-2421-2026 | Class II | Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C… | Medline Industries, LP |
| 2026-06-24 | Z-2422-2026 | Class II | Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K… | Medline Industries, LP |
| 2026-06-24 | Z-2423-2026 | Class II | Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS… | Medline Industries, LP |
| 2026-06-24 | Z-2424-2026 | Class II | Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB… | Medline Industries, LP |
| 2026-06-24 | Z-2425-2026 | Class II | Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662 | Medline Industries, LP |
| 2026-06-24 | Z-2426-2026 | Class II | Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359 | Medline Industries, LP |
| 2026-06-24 | Z-2427-2026 | Class II | Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D | Medline Industries, LP |
| 2026-06-24 | Z-2428-2026 | Class II | Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK… | Medline Industries, LP |
| 2026-06-24 | Z-2429-2026 | Class II | Medline convenience kit: | Medline Industries, LP |
| 2026-06-24 | Z-2430-2026 | Class II | Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M | Medline Industries, LP |
| 2026-06-24 | Z-2431-2026 | Class II | Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I… | Medline Industries, LP |
| 2026-06-24 | Z-2432-2026 | Class II | Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK… | Medline Industries, LP |
| 2026-06-24 | Z-2433-2026 | Class II | Medline convenience kits: WT LAVH PACK DYNJ46609F | Medline Industries, LP |
| 2026-06-24 | Z-2434-2026 | Class II | Medline convenience kits: DAVINCI MAIN DYNJ908031D | Medline Industries, LP |
| 2026-06-24 | Z-2435-2026 | Class II | Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS… | Medline Industries, LP |
| 2026-06-24 | Z-2436-2026 | Class II | Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B… | Medline Industries, LP |
| 2026-06-24 | Z-2437-2026 | Class II | Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B… | Medline Industries, LP |
| 2026-06-24 | Z-2438-2026 | Class II | Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT… | Medline Industries, LP |
| 2026-06-24 | Z-2439-2026 | Class II | Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8 | Medline Industries, LP |
| 2026-06-24 | Z-2440-2026 | Class II | Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT… | Medline Industries, LP |
| 2026-06-24 | Z-2441-2026 | Class II | Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK… | Medline Industries, LP |
| 2026-06-24 | Z-2442-2026 | Class II | Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B | Medline Industries, LP |
| 2026-06-24 | Z-2443-2026 | Class II | Medline convenience kits: PORT A CATH DYNJ906818A | Medline Industries, LP |
| 2026-06-24 | Z-2444-2026 | Class II | Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC… | Medline Industries, LP |
| 2026-06-24 | Z-2445-2026 | Class II | Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED… | Medline Industries, LP |
| 2026-06-24 | Z-2446-2026 | Class II | Medline convenience kits: C SECTION CDS985505G C SECTION PACK… | Medline Industries, LP |
| 2026-06-24 | Z-2447-2026 | Class II | Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L | Medline Industries, LP |
| 2026-06-24 | Z-2448-2026 | Class II | HarmonyAIR A-Series Surgical Lighting System | Steris Corporation |
| 2026-06-24 | Z-2449-2026 | Class II | HarmonyAIR A-Series Surgical Lighting System | Steris Corporation |
| 2026-06-24 | Z-2450-2026 | Class II | ALYON Surgical Lighting System | Steris Corporation |
| 2026-06-24 | Z-2451-2026 | Class II | Medtronic O-arm O2 Imaging System | Medtronic Navigation, Inc.-Boxborough |
| 2026-06-24 | Z-2456-2026 | Class II | TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 | Smith & Nephew, Inc. |
| 2026-06-24 | Z-2457-2026 | Class I | Impella CP Set with SmartAssist | Abiomed, Inc. |
| 2026-06-24 | Z-2458-2026 | Class II | Ritmed Neurological Sponges | AMD Medicom Inc. |
| 2026-06-24 | Z-2459-2026 | Class II | Ritmed Neurological Sponges | AMD Medicom Inc. |
| 2026-06-24 | Z-2460-2026 | Class II | directCHECK ACT-LR whole blood quality control | Accriva Diagnostics, Inc. |
| 2026-06-24 | Z-2461-2026 | Class II | TRI TS BASEPLATE SIZE 3 | Howmedica Osteonics Corp. |
| 2026-06-24 | Z-2462-2026 | Class II | TRI TS BASEPLATE SIZE 4 | Howmedica Osteonics Corp. |
| 2026-06-24 | Z-2464-2026 | Class II | ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip | ConMed Corporation |
| 2026-06-24 | Z-2465-2026 | Class II | ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip | ConMed Corporation |
| 2026-06-24 | Z-2466-2026 | Class II | ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip | ConMed Corporation |
| 2026-06-24 | Z-2467-2026 | Class II | ConMed AirSeal 8mm Access Port and Low Profile Obturator with… | ConMed Corporation |
| 2026-06-24 | Z-2468-2026 | Class II | ConMed AirSeal 8mm Access Port and Low Profile Obturator with… | ConMed Corporation |
| 2026-06-24 | Z-2469-2026 | Class II | ConMed AirSeal 5mm Access Port and Low Profile Obturator with… | ConMed Corporation |
| 2026-06-24 | Z-2470-2026 | Class II | ConMed AirSeal 5mm Access Port and Low Profile Obturator with… | ConMed Corporation |
| 2026-06-24 | Z-2471-2026 | Class II | ConMed AirSeal 5mm Access Port and Low Profile Obturator with… | ConMed Corporation |
| 2026-06-24 | Z-2472-2026 | Class II | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with… | ConMed Corporation |
| 2026-06-24 | Z-2473-2026 | Class II | ConMed AirSeal 12mm Access Port and Low Profile Obturator with… | ConMed Corporation |
| 2026-06-24 | Z-2474-2026 | Class II | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with… | ConMed Corporation |
| 2026-06-24 | Z-2475-2026 | Class II | Giraffe OmniBed | GE Medical Systems, LLC |
| 2026-06-24 | Z-2476-2026 | Class II | Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1 | GE Medical Systems, LLC |
| 2026-06-24 | Z-2477-2026 | Class II | Giraffe OmniBed Field Replaceable Unit | GE Medical Systems, LLC |
| 2026-06-24 | Z-2478-2026 | Class II | Mito Red Light | MITO RED LIGHT INC |
| 2026-06-24 | Z-2479-2026 | Class II | MEDLINE Urethral Catheter | Medline Industries, LP |
| 2026-06-24 | Z-2480-2026 | Class II | MEDLINE Urethral Catheterization Tray | Medline Industries, LP |
| 2026-06-24 | Z-2481-2026 | Class II | MEDLINE Pre-connected Urethral Catheterization Tray and Bag | Medline Industries, LP |
| 2026-06-24 | Z-2482-2026 | Class II | MEDLINE Urethral Catheterization Tray and Bag | Medline Industries, LP |
| 2026-06-24 | Z-2483-2026 | Class II | MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection… | Medline Industries, LP |
| 2026-06-24 | Z-2484-2026 | Class II | MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection… | Medline Industries, LP |
| 2026-06-24 | Z-2485-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED | Medline Industries, LP |
| 2026-06-24 | Z-2486-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK | Medline Industries, LP |
| 2026-06-24 | Z-2487-2026 | Class II | MEDLINE Medical Procedure Kits labeled as CH OPEN HEART | Medline Industries, LP |
| 2026-06-24 | Z-2488-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK | Medline Industries, LP |
| 2026-06-24 | Z-2489-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY… | Medline Industries, LP |
| 2026-06-24 | Z-2490-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION | Medline Industries, LP |
| 2026-06-24 | Z-2491-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE… | Medline Industries, LP |
| 2026-06-24 | Z-2492-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S… | Medline Industries, LP |
| 2026-06-24 | Z-2493-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO | Medline Industries, LP |
| 2026-06-24 | Z-2494-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH | Medline Industries, LP |
| 2026-06-24 | Z-2495-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY… | Medline Industries, LP |
| 2026-06-24 | Z-2496-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN | Medline Industries, LP |
| 2026-06-24 | Z-2497-2026 | Class II | MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT | Medline Industries, LP |
| 2026-06-24 | Z-2498-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ | Medline Industries, LP |
| 2026-06-24 | Z-2499-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: NURSING KIT | Medline Industries, LP |
| 2026-06-24 | Z-2500-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK | Medline Industries, LP |
| 2026-06-24 | Z-2501-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK | Medline Industries, LP |
| 2026-06-24 | Z-2502-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK | Medline Industries, LP |
| 2026-06-24 | Z-2503-2026 | Class II | MEDLINE Medical Procedure Kits labeled as BASIC GYN | Medline Industries, LP |
| 2026-06-24 | Z-2504-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK | Medline Industries, LP |
| 2026-06-24 | Z-2505-2026 | Class II | MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY | Medline Industries, LP |
| 2026-06-24 | Z-2506-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY | Medline Industries, LP |
| 2026-06-24 | Z-2507-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS | Medline Industries, LP |
| 2026-06-24 | Z-2508-2026 | Class II | MEDLINE Medical Procedure Kits labeled as: 1) CRANI | Medline Industries, LP |
| 2026-06-24 | Z-2509-2026 | Class II | Product Name: STAAR ICL Calculation Software Software Version:… | Staar Surgical AG |
| 2026-06-24 | Z-2513-2026 | Class II | iLet Bionic Pancreas | Beta Bionics, Inc. |
| 2026-06-24 | Z-2514-2026 | Class II | BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106… | BD SWITZERLAND SARL |
| 2026-06-24 | Z-2515-2026 | Class II | Brand Name: Inspire Medical Systems | Inspire Medical Systems Inc. |
| 2026-06-24 | Z-2516-2026 | Class II | Brand Name: Inspire Medical Systems | Inspire Medical Systems Inc. |
| 2026-06-24 | Z-2517-2026 | Class II | Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes:… | Merit Medical Systems, Inc. |
| 2026-06-24 | Z-2518-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular… | Thoratec LLC |
| 2026-06-24 | Z-2519-2026 | Class II | Brand Name: HeartMate Product Name: HeartMate 3" System Controller… | Thoratec LLC |
| 2026-06-24 | Z-2520-2026 | Class II | Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery | Thoratec LLC |
| 2026-06-17 | Z-2280-2026 | Class II | Fresh Roast Systems ColorTrack | Fresh Roast Systems Inc |
| 2026-06-17 | Z-2311-2026 | Class II | Plum Solo Precision IV Pump | ICU Medical, Inc. |
| 2026-06-17 | Z-2312-2026 | Class II | Plum Duo Infusion Pump | ICU Medical, Inc. |
| 2026-06-17 | Z-2313-2026 | Class II | Plum Duo Precision IV Pump | ICU Medical, Inc. |
| 2026-06-17 | Z-2314-2026 | Class II | Allia IGS 3 Pulse angiographic X-ray system | GE Medical Systems, LLC |
| 2026-06-17 | Z-2315-2026 | Class II | Allia IGS 5 Pulse angiographic X-ray system | GE Medical Systems, LLC |
| 2026-06-17 | Z-2316-2026 | Class II | Allia IGS 7 Pulse angiographic X-ray system | GE Medical Systems, LLC |
| 2026-06-17 | Z-2317-2026 | Class II | Allia IGS Pulse angiographic X-ray system | GE Medical Systems, LLC |
| 2026-06-17 | Z-2318-2026 | Class II | Allia Moveo angiographic X-ray system | GE Medical Systems, LLC |
| 2026-06-17 | Z-2319-2026 | Class II | Mahurkar Elite PASS Trays | Mozarc Medical US LLC |
| 2026-06-17 | Z-2320-2026 | Class II | EXCOR Pediatric Ventricular Assist Device | BERLIN HEART GMBH |
| 2026-06-17 | Z-2321-2026 | Class II | Bicarby" Dialysate | Fresenius Medical Care Holdings, Inc. |
| 2026-06-17 | Z-2322-2026 | Class II | TDC VELOCE" | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| 2026-06-17 | Z-2323-2026 | Class II | TDC VELOCE" | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| 2026-06-17 | Z-2324-2026 | Class II | TDC VELOCE" | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| 2026-06-17 | Z-2325-2026 | Class II | Brand Name: CGuard¿ Prime Carotid Stent System | INSPIREMD Inc |
| 2026-06-17 | Z-2326-2026 | Class II | Brand Name: CGuard¿ Prime Carotid Stent System | INSPIREMD Inc |
| 2026-06-17 | Z-2327-2026 | Class II | CGuard Prime Carotid Stent System | INSPIREMD Inc |
| 2026-06-17 | Z-2328-2026 | Class II | Brand Name: CGuard Prime Carotid Stent System | INSPIREMD Inc |
| 2026-06-17 | Z-2329-2026 | Class II | CGuard Prime Carotid Stent System | INSPIREMD Inc |
| 2026-06-17 | Z-2330-2026 | Class II | CGuard¿ Prime Carotid Stent System | INSPIREMD Inc |
| 2026-06-17 | Z-2331-2026 | Class II | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE | HF Acquisition Co LLC |
| 2026-06-17 | Z-2332-2026 | Class II | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE | HF Acquisition Co LLC |
| 2026-06-17 | Z-2333-2026 | Class II | Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2334-2026 | Class II | Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2335-2026 | Class II | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312 | Avanos Medical, Inc. |
| 2026-06-17 | Z-2336-2026 | Class II | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316 | Avanos Medical, Inc. |
| 2026-06-17 | Z-2337-2026 | Class II | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2338-2026 | Class II | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2339-2026 | Class II | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2340-2026 | Class II | Product Name: CORFLO Safety PEG Kit with ENFit Connector… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2341-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2342-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2343-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2344-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2345-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2346-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2347-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2348-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2349-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2350-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2351-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2352-2026 | Class II | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit… | Avanos Medical, Inc. |
| 2026-06-17 | Z-2353-2026 | Class II | SD LTM 64 PLUS | Micromed S.p.A. |
| 2026-06-17 | Z-2354-2026 | Class II | DigitalDiagnost C90 Flex/Value/Chest/ER | Philips North America Llc |
| 2026-06-17 | Z-2355-2026 | Class II | NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number… | In2bones USA, LLC |
| 2026-06-17 | Z-2356-2026 | Class II | NexxZr T Multi A3 | Sagemax Bioceramics, Inc. |
| 2026-06-17 | Z-2361-2026 | Class II | Medartis APTUS | Medartis AG |
| 2026-06-17 | Z-2362-2026 | Class II | Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog… | The Binding Site Group, Ltd. |
| 2026-06-17 | Z-2398-2026 | Class II | Siemens Dimension Tacrolimus Flex Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. |
| 2026-06-17 | Z-2399-2026 | Class II | Hintermann Series Talar Implant | DT MedTech, LLC |
| 2026-06-17 | Z-2400-2026 | Class II | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit | Inter-Med Llc |
| 2026-06-17 | Z-2401-2026 | Class II | Bicarby Dialysate | Fresenius Medical Care Holdings, Inc. |
| 2026-06-17 | Z-2402-2026 | Class II | Boston Scientific CSK Electrodes: REF: CSK-TC10 | Boston Scientific Neuromodulation Corporation |
| 2026-06-17 | Z-2403-2026 | Class II | Boston Scientific TCN Electrodes: REF: TCN-5 | Boston Scientific Neuromodulation Corporation |
| 2026-06-17 | Z-2404-2026 | Class II | Boston Scientific Model SC-4318 | Boston Scientific Neuromodulation Corporation |