Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 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 40 of 808
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
SEDECAL SA
Model Number 40KW-FX.899, Mobile X-ray system
SEDECAL SA
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly…
Theken Companies LLC
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUT…
Becton Dickinson & Co.
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
SEDECAL SA
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
SEDECAL SA
SM_40HF_B_D_VIR3.004, Mobile X-ray system
SEDECAL SA
Model Number 40KWFXPLUS.889, Mobile X-ray system
SEDECAL SA
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut …
ICU Medical, Inc.
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
SEDECAL SA
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA…
Synthes (USA) Products LLC
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
SEDECAL SA
SM_40HF_BDC, Mobile X-ray system
SEDECAL SA
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
RADPRO MOBILE, Mobile X-ray system
SEDECAL SA
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Cod…
GE Medical Systems, LLC
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 100043…
Abiomed, Inc.
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray t…
Wipro GE Healthcare Private Ltd.
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Beckman Coulter, Inc.
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UN…
Becton Dickinson & Co.
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
SEDECAL SA
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Model Number 40KWMOBILE3.899, Mobile X-ray system
SEDECAL SA
Model Number 40KWFXPLUS.005, Mobile X-ray system
SEDECAL SA
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
Cardinal Health 200, LLC
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
SEDECAL SA
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Pr…
B BRAUN MEDICAL INC
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
UIH Technologies LLC
Model Number 40KWFXPLUS.002, Mobile X-ray system
SEDECAL SA
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
UIH Technologies LLC
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
SEDECAL SA
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the…
Becton Dickinson & Co.
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12F…
Cardinal Health 200, LLC
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
SEDECAL SA
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument To…
Becton Dickinson & Co.
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
SEDECAL SA
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
SEDECAL SA
Model Number 40KWFXPLUS-710CW, Mobile X-ray system
SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
SEDECAL SA
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
LeMaitre Vascular, Inc.
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
SEDECAL SA
SED URS LP, Mobile X-ray system
SEDECAL SA
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 2, 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 2, 2026.