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 · 2026-08-24
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 507 of 819
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sys…
SPINEART SA
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sys…
SPINEART SA
Phadia 1000 Instrument, Article Number 12-3800-01.
Phadia US Inc
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at d…
Philips Medical Systems (Cleveland) Inc
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Stryker Neurovascular
ACCOLADE DR Pacemaker
Boston Scientific Corporation
ACCOLADE SR Pacemaker
Boston Scientific Corporation
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles f…
Owen Mumford USA, Inc.
ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG o…
Philips Electronics North America Corporation
PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed …
TEI Biosciences
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS…
Fujifilm Medical Systems U.S.A., Inc.
VISIONIST CRT-P Pacemaker
Boston Scientific Corporation
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles f…
Owen Mumford USA, Inc.
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older wh…
Zoll Manufacturing Corp.
ESSENTIO DR Pacemaker
Boston Scientific Corporation
ALTRUA 2 EL DR Pacemaker
Boston Scientific Corporation
ACCOLADE MRI EL DR Pacemaker
Boston Scientific Corporation
Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administra…
Valeant Pharmacueticals International
PROPONENT DR Pacemaker
Boston Scientific Corporation
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sys…
SPINEART SA
VALITUDE CRT-P Pacemaker
Boston Scientific Corporation
PROPONENT EL DR Pacemaker
Boston Scientific Corporation
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and…
Philips Medical Systems (Cleveland) Inc
ACCOLADE MRI DR Pacemaker
Boston Scientific Corporation
ACCOLADE MRI SR Pacemaker
Boston Scientific Corporation
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, …
DeRoyal Industries Inc
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sys…
SPINEART SA
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sy…
SPINEART SA
Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at diffe…
Philips Medical Systems (Cleveland) Inc
ESSENTIO SR Pacemaker
Boston Scientific Corporation
ALTRUA 2 SR Pacemaker
Boston Scientific Corporation
ESSENTIO MRI SR Pacemaker
Boston Scientific Corporation
ESSENTIO MRI EL DR Pacemaker
Boston Scientific Corporation
ACCOLADE EL DR Pacemaker
Boston Scientific Corporation
RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide tr…
RAYSEARCH LABORATORIES AB
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combinat…
Roche Diagnostics Corporation
VALITUDE X4 CRT-P Pacemaker
Boston Scientific Corporation
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine …
Fujifilm Medical Systems U.S.A., Inc.
ESSENTIO EL DR Pacemaker
Boston Scientific Corporation
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sys…
SPINEART SA
VISIONIST X4 CRT-P Pacemaker
Boston Scientific Corporation
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Hologic, Inc.
PROPONENT VDD SL Pacemaker
Boston Scientific Corporation
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate Sys…
SPINEART SA
ALTRUA 2 DR Pacemaker
Boston Scientific Corporation
Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold …
Merge Healthcare, Inc.
Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or t…
Hamilton Medical, Inc.
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Medtronic Sofamor Danek USA Inc
ESSENTIO MRI DR Pacemaker
Boston Scientific Corporation
Persona Partial Knee System, Size 8, Finishing Guide
Zimmer Biomet, 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.