Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,910 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 recalls
- FDA Food 35
FDA Food
35 recalls
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 362 of 819
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Fridababy LLC
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10
Arrow International Inc
Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Naut…
Pacific Medical Group Inc.
Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language spec…
Flowonix Medical Inc
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
Stryker Corporation
Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and scre…
Nextremity Solutions
FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK
Arrow International Inc
ROSA One 3.1 Brain Application
MEDTECH SAS
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorpo…
Terumo Cardiovascular Systems Corporation
Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Medicrea International
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN
Arrow International Inc
Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH
Arrow International Inc
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP
Arrow International Inc
Revanesse Versa, PN40081
Prollenium Medical Technologies Inc.
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perfo…
LivaNova USA Inc.
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00…
Blue Ortho
Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
Medtronic Inc.
FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B
Arrow International Inc
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depressio…
LivaNova USA Inc
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracor…
Terumo Cardiovascular Systems Corporation
Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-15…
Medtronic Inc.
Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-…
Microvention, Inc.
EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL
Arrow International Inc
Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 11…
Respironics California, LLC
External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific…
Pacific Medical Group Inc.
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Implant Direct Sybron Manufacturing LLC
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
bioMerieux, Inc.
EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI
Arrow International Inc
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1
Arrow International Inc
US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
Flowonix Medical Inc
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B
Arrow International Inc
Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
Flowonix Medical Inc
Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461
Respironics California, LLC
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH
Arrow International Inc
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Roche Diagnostics Operations, Inc.
Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulatio…
Terumo Cardiovascular Systems Corporation
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E
Arrow International Inc
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide …
Cardiac Assist, Inc
Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable …
Pacific Medical Group Inc.
Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language s…
Flowonix Medical Inc
Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN…
Dexcom Inc
Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus …
Pacific Medical Group Inc.
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
Arrow International Inc
Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracor…
Terumo Cardiovascular Systems Corporation
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jul 29, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 29, 2026.