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 460 of 819
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Guardian Pharmacy Services
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX…
Guardian Pharmacy Services
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Leica Microsystems, Inc.
radial stem 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.
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accesso…
ICU Medical, Inc.
88" (224 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.
Radio Capitellum Small, 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.
Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial…
Howmedica Osteonics Corp.
rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head a…
Howmedica Osteonics Corp.
120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tub…
ICU Medical, Inc.
#4 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.
Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as…
ICU Medical, Inc.
Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial He…
Howmedica Osteonics Corp.
Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial…
Howmedica Osteonics Corp.
rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head…
Howmedica Osteonics Corp.
132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing ac…
ICU Medical, Inc.
Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepar…
Think Surgical, Inc.
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with…
Vyaire Medical
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Smiths Medical ASD Inc.
radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and U…
Howmedica Osteonics Corp.
Q-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 patient …
Arjohuntleigh Magog
Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial…
Howmedica Osteonics Corp.
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.
98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing acces…
ICU Medical, Inc.
164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating L…
ICU Medical, Inc.
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is …
ICU Medical, Inc.
125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Sterile The…
ICU Medical, Inc.
Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head …
Howmedica Osteonics Corp.
143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Steril…
ICU Medical, Inc.
#2 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.
Radio Capitellum Large, 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 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and…
Howmedica Osteonics Corp.
#1 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.
115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Sterile The …
ICU Medical, Inc.
112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Conn…
ICU Medical, Inc.
116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE …
ICU Medical, Inc.
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a …
ICU Medical, Inc.
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrument…
Qiagen Sciences, Inc.
162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Steri…
ICU Medical, Inc.
168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, steril…
ICU Medical, Inc.
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Nu…
Vyaire Medical
100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing access…
ICU Medical, Inc.
105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL…
ICU Medical, Inc.
#3 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.
107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile The blood tubi…
ICU Medical, Inc.
218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector, Rotating Luer, Sterile The blood tubing…
ICU Medical, Inc.
Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow sy…
Howmedica Osteonics Corp.
rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial He…
Howmedica Osteonics Corp.
139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pierced Port, …
ICU Medical, Inc.
Radio Capitellum Broach Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-…
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.