Class I medical devices recalls – page 2

• ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella CP Set, Pump Set Code 0048-0003… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323… recall
  FDA July 22, 2026 · Abiomed, Inc. · Class I
• Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away… recall
  FDA July 22, 2026 · Oscor Inc. · Class I
• Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away… recall
  FDA July 22, 2026 · Oscor Inc. · Class I
• Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away… recall
  FDA July 22, 2026 · Oscor Inc. · Class I
• Medtronic Harmony Delivery Catheter System recall
  FDA July 8, 2026 · Medtronic Heart Valves Division · Class I
• A M S, ALIGNED MEDICAL SOLUTIONS, Dr recall
  FDA July 8, 2026 · Windstone Medical Packaging, Inc. · Class I
• A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227… recall
  FDA July 8, 2026 · Windstone Medical Packaging, Inc. · Class I
• A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX… recall
  FDA July 8, 2026 · Windstone Medical Packaging, Inc. · Class I
• A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B… recall
  FDA July 8, 2026 · Windstone Medical Packaging, Inc. · Class I
• Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no recall
  FDA July 8, 2026 · Medline Industries, LP · Class I
• Omnipod (Eros) Pod recall
  FDA July 8, 2026 · Insulet Corporation · Class I
• Omnipod DASH Pod recall
  FDA July 8, 2026 · Insulet Corporation · Class I
• Omnipod 5 Pods recall
  FDA July 8, 2026 · Insulet Corporation · Class I
• Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit)… recall
  FDA July 8, 2026 · Baxter Healthcare Corporation · Class I
• Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model recall
  FDA July 8, 2026 · Baxter Healthcare Corporation · Class I
• Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model recall
  FDA July 8, 2026 · Baxter Healthcare Corporation · Class I
• Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model recall
  FDA July 8, 2026 · Baxter Healthcare Corporation · Class I
• Breathing circuit set, coaxial recall
  FDA July 8, 2026 · Hamilton Medical AG · Class I
• Abiomed Impella CP Set with SmartAssist (10th Generation) containing… recall
  FDA July 1, 2026 · Abiomed, Inc. · Class I
• Abiomed Impella CP Set with SmartAssist (10th Generation) containing… recall
  FDA July 1, 2026 · Abiomed, Inc. · Class I
• Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP… recall
  FDA July 1, 2026 · Abiomed, Inc. · Class I
• Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP… recall
  FDA July 1, 2026 · Abiomed, Inc. · Class I
• Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE… recall
  FDA July 1, 2026 · Medline Industries, LP · Class I
• Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO… recall
  FDA July 1, 2026 · Medline Industries, LP · Class I
• Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q recall
  FDA July 1, 2026 · Medline Industries, LP · Class I
• Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA -… recall
  FDA July 1, 2026 · Medline Industries, LP · Class I
• Impella CP Set with SmartAssist recall
  FDA June 24, 2026 · Abiomed, Inc. · Class I
• REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PICC ACCESS TRAY/ASK-04001-CG1 recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: ACCESS TRAY/ASK-04001-MC3 recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PARACENTESIS KIT/ASK-00376-JHH recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I
• REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA:… recall
  FDA June 24, 2026 · Arrow International, LLC · Class I