Sorin Group USA, Inc.
52 recalls on record · Latest: Nov 15, 2017
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Agency notice ledger
Federal filing book Sorin Group USA, Inc. MID-BOOK · SINGLE-AGENCY
#341 of 14,151 · 52 notices · 0.050% archive
- BOOK 52 notices
- RANK #341 of 14,151
- SHARE 0.050% archive
- AGENCY FDA Devices (52)
- CAT medical devices
- CATS 1 category
- LATEST Nov 15, 2017
- PHOTO Adams Extract
Nearest notice-volume peer: Adams Extract & Spice LLC (0 notice gap)
Sorin Group USA, Inc. accounts for about 0.050% of the 104,423-notice archive on 52 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
Where Sorin Group USA, Inc. sits among 14,151 recalling firms
Sorin Group USA, Inc. ranks 341st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Sorin Group USA, Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
52 341st of 14151 higher than 13,809 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Sorin Group USA, Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
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Sorin Group USA, Inc.
52 notices
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What this shows Sorin Group USA, Inc. holds about 0.050% of archive notices alongside 52 distinct filings.
FDA Devices Moderate Nov 15, 2017
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced
FDA Devices Moderate Aug 16, 2017
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
FDA Devices Moderate Aug 9, 2017
NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
FDA Devices Moderate Aug 2, 2017
STOCKERT Heater-Cooler System 3T, 120V/60 Hz
FDA Devices Moderate Aug 2, 2017
STOCKERT Heater-Cooler System 3T, 230 V
FDA Devices Moderate Aug 2, 2017
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
FDA Devices Moderate Aug 2, 2017
STOCKERT Heater-Cooler System 3T, 240V/60 Hz
FDA Devices Moderate Aug 2, 2017
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
FDA Devices Moderate Aug 2, 2017
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
FDA Devices Moderate Dec 14, 2016
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
FDA Devices Moderate Dec 7, 2016
ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Devices Moderate Nov 23, 2016
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
FDA Devices Moderate Nov 23, 2016
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
FDA Devices Moderate Sep 28, 2016
St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
FDA Devices Moderate Sep 14, 2016
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect. The
FDA Devices Moderate Sep 14, 2016
Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct conta
FDA Devices Moderate Jul 20, 2016
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor o
FDA Devices Moderate Mar 23, 2016
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
FDA Devices Low Mar 2, 2016
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART pack
FDA Devices Moderate Feb 24, 2016
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.
FDA Devices Moderate Jul 22, 2015
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
FDA Devices Moderate Jul 22, 2015
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
FDA Devices Moderate Jul 22, 2015
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
FDA Devices Moderate Jul 22, 2015
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
FDA Devices Moderate Jul 22, 2015
Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
FDA Devices Moderate Jul 22, 2015
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
FDA Devices Moderate Aug 28, 2013
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
FDA Devices Moderate Mar 20, 2013
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
FDA Devices Moderate Nov 14, 2012
Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
FDA Devices Moderate Nov 14, 2012
S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
FDA Devices Moderate Nov 14, 2012
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
FDA Devices Moderate Nov 14, 2012
S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
FDA Devices Moderate Nov 14, 2012
S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
FDA Devices Moderate Nov 7, 2012
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
FDA Devices Moderate Nov 7, 2012
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
Sorin Group USA, Inc. holds a measurable archive slice
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (52 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Sorin Group USA, Inc.? ▼
PlainRecalls indexes 52 distinct federal recall events naming Sorin Group USA, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Sorin Group USA, Inc. sit among other recalling firms? ▼
Sorin Group USA, Inc. ranks #341 of 14,151 by distinct recall-event count among 14,151 firms in this archive (98th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Sorin Group USA, Inc.'s notices? ▼
FDA Devices accounts for 52 of this firm's 52 indexed notices.
What product category dominates Sorin Group USA, Inc.'s filing book? ▼
Filings for Sorin Group USA, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Sorin Group USA, Inc.: 52 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Sorin Group USA, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026