Product category · Updated Aug 19, 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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.
- 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.
- 41,070
- 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
41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-27
Do more recalls mean more Class I danger?
Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.
Read the chart, every category as text
Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.
| Category | Recalls | Vol %ile | Classified | Class I | Class I % | Rate %ile |
|---|---|---|---|---|---|---|
| Medical Devices | 41,070 | 100 | 40,763 | 3,653 | 9% | 14 |
| Food | 25,513 | 86 | 25,222 | 11,676 | 46.3% | 86 |
| Drugs & Medications | 14,473 | 71 | 14,417 | 1,508 | 10.5% | 29 |
| Children & Baby Products | 4,017 | 57 | 2,483 | 352 | 14.2% | 43 |
| Dietary Supplements | 2,018 | 43 | 1,993 | 466 | 23.4% | 71 |
| Meat & Poultry | 1,672 | 29 | 1,672 | 1,145 | 68.5% | 100 |
| Cosmetics & Personal Care | 1,388 | 14 | 1,289 | 203 | 15.7% | 57 |
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 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 154 of 822
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Randox Laboratories Ltd.
Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
Think Surgical, Inc.
DCA Systems HbA1c Reagent Kit
Siemens Healthcare Diagnostics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
Angiodynamics, Inc.
Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
Mckesson Medical-Surgical Inc. Corporate Office
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Fresenius Kabi USA, LLC
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Waldemar Link GmbH & Co. KG (Mfg Site)
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
Beaver Visitec International, Inc.
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Fresenius Kabi USA, LLC
L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
Peter Lazic Gmbh
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Baxter Healthcare Corporation
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180¿ and c
Biosense Webster, Inc.
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Medos International Sarl
Atellica IM Erythropoietin (EPO) Assay (100 Test)
Siemens Healthcare Diagnostics, Inc.
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Waldemar Link GmbH & Co. KG (Mfg Site)
D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Peter Lazic Gmbh
EasyPoint Needle, 25G x 5/8", REF: 82091
Retractable Technologies, Inc.
D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
Peter Lazic Gmbh
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
Waldemar Link GmbH & Co. KG (Mfg Site)
L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
Peter Lazic Gmbh
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Siemens Healthcare Diagnostics, Inc.
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
Waldemar Link GmbH & Co. KG (Mfg Site)
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Baxter Healthcare Corporation
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
MEDLINE INDUSTRIES, LP - Northfield
Shimadzu, Trinias, Digital Angiography System
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
Peter Lazic Gmbh
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Synthes (USA) Products LLC
Synapse PACS - Version 7.2.100
FUJIFILM Healthcare Americas Corporation
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
Synthes (USA) Products LLC
Synapse PACS - Version 7.1.000
FUJIFILM Healthcare Americas Corporation
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
ConvaTec, Inc
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Synthes (USA) Products LLC
BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
CareFusion 303, Inc.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Ortho-Clinical Diagnostics, Inc.
Synapse PACS - Version 7.2.000
FUJIFILM Healthcare Americas Corporation
Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW
Invacare Corporation
DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
Aesculap Inc
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Howmedica Osteonics Corp.
Synapse PACS - Version 7.1.000US
FUJIFILM Healthcare Americas Corporation
VITROS XT 7600 Integrated System, Catalog No. 6844461
Ortho-Clinical Diagnostics, Inc.
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
Aesculap Inc
Embrace Drill Tower, Wedged (25mm)
Waldemar Link GmbH & Co. KG (Mfg Site)
X3 TRIATHLON CS INSERT NO 6 10 MM
Howmedica Osteonics Corp.
VITROS 5600 Integrated System (New and Refurbished)
Ortho-Clinical Diagnostics, Inc.
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
Synthes (USA) Products LLC
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit wit
Avanos Medical, Inc.
MRI system: Vantage Elan, Model: MRT-2020
Canon Medical System, USA, INC.
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
Aesculap Inc
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Synthes (USA) Products LLC
VITROS XT7600 Integrated System
Ortho-Clinical Diagnostics, 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 Aug 19, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.