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
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
40,910 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. 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 · NHTSA federal recall filings · 2026-08-27
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 574 of 819
4205 Journey Rolling Walker Product Usage: used to assist people in walking
Nova Ortho-Med Inc
Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Zimmer Biomet, Inc.
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partial…
Keystone Dental Inc
ReTurn 7500/7500 Aid, transfer
Handicare USA, Inc.
Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. …
St Jude Medical Inc.
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 a…
Ortho-Clinical Diagnostics
RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a fully autom…
Roche Diagnostics Operations, Inc.
cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully …
Roche Diagnostics Operations, Inc.
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an …
Roche Diagnostics Operations, Inc.
VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of t…
Ortho-Clinical Diagnostics
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to …
Hospira Inc.
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation …
BBI SOLUTIONS OEM LTD
cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automa…
Roche Diagnostics Operations, Inc.
RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is a fu…
Roche Diagnostics Operations, Inc.
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and …
St Jude Medical Inc.
cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tub…
Roche Diagnostics Operations, Inc.
cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas…
Roche Diagnostics Operations, Inc.
Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerat…
TZ Medical, Inc.
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Lumenis Limited
Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a …
Roche Diagnostics Operations, Inc.
Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting …
Roche Diagnostics Operations, Inc.
Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD…
St Jude Medical Inc.
PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity…
Becton Dickinson & Co.
IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US);…
Siemens Healthcare Diagnostics, Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed t…
Hospira Inc.
cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: T…
Roche Diagnostics Operations, Inc.
cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The cobas p471 system is an automatic cent…
Roche Diagnostics Operations, Inc.
cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automa…
Roche Diagnostics Operations, Inc.
D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for …
Windstone Medical Packaging, Inc.
Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (…
Becton, Dickinson and Company, BD Biosciences
Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital oper…
Windstone Medical Packaging, Inc.
Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating r…
Windstone Medical Packaging, Inc.
Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating…
Windstone Medical Packaging, Inc.
Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
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.