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 462 of 819
Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow s…
Howmedica Osteonics Corp.
Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow s…
Howmedica Osteonics Corp.
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated bru…
Water Pik, Inc.
108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory wi…
ICU Medical, Inc.
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
New Era Orthopaedics, LLc
rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and U…
Howmedica Osteonics Corp.
Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a pati…
Arjohuntleigh Magog
radial head 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.
185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, steril…
ICU Medical, Inc.
Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitr…
INO therapeutics LLC/dba ikaria
Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial He…
Howmedica Osteonics Corp.
85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a …
ICU Medical, Inc.
80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with …
ICU Medical, Inc.
84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with C…
ICU Medical, Inc.
Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head …
Howmedica Osteonics Corp.
Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head …
Howmedica Osteonics Corp.
Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Un…
Howmedica Osteonics Corp.
137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile The blood tubing accessory wi…
ICU Medical, Inc.
rHead Stem Implant 6mm Collar, 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.
175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave¿, Rotating Luer, 1 Ex…
ICU Medical, Inc.
VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003
Vitalgo Inc.
rHead Recon Extended Stem Size 2. 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 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head an…
Howmedica Osteonics Corp.
125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with …
ICU Medical, Inc.
98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Luer Lock, 1 Ext, Sterile The blood tubing accessor…
ICU Medical, Inc.
84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single us…
ICU Medical, Inc.
128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, Removable 2 Gang (Blue, Yellow) 1o2¿ Manifold, Baseplate, 1 Ext, Rotating…
ICU Medical, Inc.
rHead Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and U…
Howmedica Osteonics Corp.
32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single…
ICU Medical, Inc.
120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connec…
ICU Medical, Inc.
100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory wi…
ICU Medical, Inc.
Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial He…
Howmedica Osteonics Corp.
rHead, Radial Implant 6 mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and…
Howmedica Osteonics Corp.
rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial H…
Howmedica Osteonics Corp.
Radio Capitellum Small, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow s…
Howmedica Osteonics Corp.
rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head an…
Howmedica Osteonics Corp.
119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-p…
ICU Medical, Inc.
159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubin…
ICU Medical, Inc.
88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector …
ICU Medical, Inc.
Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
Beaver Visitec
rHead, Radial Implant 6 mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and…
Howmedica Osteonics Corp.
rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head…
Howmedica Osteonics Corp.
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Stryker Neurovascular
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient dur…
Integra LifeSciences Corp.
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear He…
Envoy Medical Corporation
CT Goldseal Optima CT 600
GE Healthcare, LLC
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
LivaNova USA Inc
Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm…
Cayenne Medical Inc.
XLTEK EMU40EX EEG Headbox
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
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.