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 · 2026-09-22
Do more recalls mean more Class I danger?
Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.
Read the chart, every category as text
Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.
| Category | Recalls | Vol %ile | Classified | Class I | Class I % | Rate %ile |
|---|---|---|---|---|---|---|
| Medical Devices | 41,070 | 100 | 40,763 | 3,653 | 9% | 14 |
| Food | 25,513 | 86 | 25,222 | 11,676 | 46.3% | 86 |
| Drugs & Medications | 14,473 | 71 | 14,417 | 1,508 | 10.5% | 29 |
| Children & Baby Products | 4,017 | 57 | 2,483 | 352 | 14.2% | 43 |
| Dietary Supplements | 2,018 | 43 | 1,993 | 466 | 23.4% | 71 |
| Meat & Poultry | 1,672 | 29 | 1,672 | 1,145 | 68.5% | 100 |
| Cosmetics & Personal Care | 1,388 | 14 | 1,289 | 203 | 15.7% | 57 |
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 54 of 822
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, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head
Theken Companies LLC
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
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 Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave,
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) System and the Tibial Nail Advanced System.
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 Codes VU2 and VU4
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: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Con
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 tube
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 UNREPAIRED, Catalog Number: 44557008.
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 Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
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 BD Veritor Plus Analyzer to BD Synapsys.
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 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUM
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 Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
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
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
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.