Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U2...
Reason: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an...
Z-1771-2026May 6, 2026Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model ...
Reason: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an...
Reason: Unapproved design changes to the products outside of the 510(k) clearance.
Z-1878-2026April 29, 2026Northfield, IL
Medline Industries, LP
Class IIOngoing
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model N...
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Z-1842-2026April 29, 2026Northfield, IL
Medline Industries, LP
Class IIOngoing
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Reason: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the via...
Reason: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the via...
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope o...
Z-0512-2026November 26, 2025Northfield, IL
Medline Industries, LP
Class IIOngoing
MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, R...
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope o...
Z-0513-2026November 26, 2025Northfield, IL
Boston Scientific Corporation
Class IOngoing
Model Number U228, VISIONIST CRT-P EL MRI
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0105-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number U226, VISIONIST CRT-P EL
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0104-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L211 PROPONENT DR SL MRI Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0089-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L100, ESSENTIO SR SL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0092-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE SR SL (Model L300)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLA...
Z-0079-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L101, ESSENTIO DR SL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0093-2026October 22, 2025Saint Paul, MN
American Contract Systems Inc.
Class IIOngoing
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PAC...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0176-2026October 22, 2025Grimes, IA
Boston Scientific Corporation
Class IOngoing
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0087-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
PROPONENT SR SL (Model L200)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0085-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE DR EL MRI (Model L331)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0084-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE DR SL (Model L301)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0080-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0097-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number S701 ALTRUA 2 SR SL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0098-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE DR EL (Model L321)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0083-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L111, ESSENTIO DR SL MRI Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0095-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number U125, VALITUDE CRT-P EL
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...