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 · 2026-09-01
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 692 of 822
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Pho…
Instrumed International, Inc.
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling cat…
Pfm Medical Inc
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss…
Instrumed International, Inc.
Soft Contact Lens
Cooper Vision Caribbean Corp.
1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endos…
Stryker Endoscopy
Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitat…
Skeletal Dynamics
Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 P…
Zimmer, Inc.
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dis…
Instrumed International, Inc.
Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation, LLC
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therap…
Pfm Medical Inc
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation, LLC
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Fing…
ArthroCare Medical Corporation
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion a…
Concentric Medical Inc
Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovascu…
Concentric Medical Inc
Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
Biomet Microfixation, LLC
Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation, LLC
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFu…
Instrumed International, Inc.
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Bos…
Instrumed International, Inc.
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access t…
Pfm Medical Inc
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Biomet Microfixation, LLC
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
Biomet Microfixation, LLC
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetr…
Instrumed International, Inc.
Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g.,…
Instrumed International, Inc.
Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
Pfm Medical Inc
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Smith & Nephew, Inc.
IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mappi…
Boston Scientific Corp
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee j…
ConforMIS, Inc.
Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation, LLC
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
Pfm Medical Inc
MEVION S250, used for proton radiation therapy.
Mevion Medical Systems, Inc.
Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion bran…
Instrumed International, Inc.
Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical…
Instrumed International, Inc.
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Sym…
Instrumed International, Inc.
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural …
Pfm Medical Inc
Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 S…
Alcon Research, Ltd.
1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view …
Stryker Endoscopy
Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
Biomet Microfixation, LLC
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat …
Philips Medical Systems, Inc.
An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instrument…
Instrumed International, Inc.
Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of …
Instrumed International, Inc.
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix Internati…
Instrumed International, Inc.
Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Su…
Instrumed International, Inc.
Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the B…
Instrumed International, Inc.
Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation, LLC
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal …
Pfm Medical Inc
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation, LLC
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Smith & Nephew, Inc.
Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical …
Siemens Medical Solutions USA, Inc
Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
Remel 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.