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 · 2026-08-22
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 461 of 819
112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a s…
ICU Medical, Inc.
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, Sterile The blood …
ICU Medical, Inc.
Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni…
Howmedica Osteonics Corp.
radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and U…
Howmedica Osteonics Corp.
#4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and …
Howmedica Osteonics Corp.
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single u…
ICU Medical, Inc.
rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head…
Howmedica Osteonics Corp.
rHead Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-…
Howmedica Osteonics Corp.
132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing accessory wi…
ICU Medical, Inc.
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the tho…
Medtronic Sofamor Danek USA Inc
rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head an…
Howmedica Osteonics Corp.
32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single …
ICU Medical, Inc.
rHead Recon Extended Stem Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbo…
Howmedica Osteonics Corp.
rHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and…
Howmedica Osteonics Corp.
134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Sterile The blood…
ICU Medical, Inc.
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to gene…
Hudson Scientific LLC
Radio Capitellum, Recon Head, Size #4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni…
Howmedica Osteonics Corp.
rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head…
Howmedica Osteonics Corp.
121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 2 Ext, Ster…
ICU Medical, Inc.
#3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial He…
Howmedica Osteonics Corp.
rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-E…
Howmedica Osteonics Corp.
147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1…
ICU Medical, Inc.
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing acces…
ICU Medical, Inc.
Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head …
Howmedica Osteonics Corp.
Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunc…
ICU Medical, Inc.
117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blood tubi…
ICU Medical, Inc.
rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial He…
Howmedica Osteonics Corp.
rHead Recon Extended Stem Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbo…
Howmedica Osteonics Corp.
rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head a…
Howmedica Osteonics Corp.
126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing …
ICU Medical, Inc.
#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial He…
Howmedica Osteonics Corp.
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which …
Boston Scientific Corporation
Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow sy…
Howmedica Osteonics Corp.
Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni…
Howmedica Osteonics Corp.
135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing acces…
ICU Medical, Inc.
rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and U…
Howmedica Osteonics Corp.
radial head implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and U…
Howmedica Osteonics Corp.
rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head an…
Howmedica Osteonics Corp.
Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head …
Howmedica Osteonics Corp.
rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-…
Howmedica Osteonics Corp.
Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head …
Howmedica Osteonics Corp.
rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and U…
Howmedica Osteonics Corp.
rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial H…
Howmedica Osteonics Corp.
radial head implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and U…
Howmedica Osteonics Corp.
Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Exp…
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
radial stem implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and U…
Howmedica Osteonics Corp.
rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head a…
Howmedica Osteonics Corp.
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080…
Datex-Ohmeda, Inc.
99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Conne…
ICU Medical, Inc.
Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial He…
Howmedica Osteonics Corp.
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.