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 87 of 808
MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
MEDLINE INDUSTRIES, LP - Northfield
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Orthoscan, Inc.
Diode Laser Hair Removal model: WLA-01
WINGDERM ELECTRO-OPTICS LTD.
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3…
MEDLINE INDUSTRIES, LP - Northfield
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
GE Healthcare (China) Co., Ltd.
Atellica CI Analyzer. Catalog Numbers: 10947347.
Siemens Healthcare Diagnostics, Inc.
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Becton Dickinson & Co.
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Becton Dickinson & Co.
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wou…
Advanced Medical Solutions Ltd.
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Becton Dickinson & Co.
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF C…
MEDLINE INDUSTRIES, LP - Northfield
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Se…
GE Healthcare (China) Co., Ltd.
MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, RE…
MEDLINE INDUSTRIES, LP - Northfield
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acu…
Advanced Medical Solutions Ltd.
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
MEDLINE INDUSTRIES, LP - Northfield
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Smith & Nephew Inc.
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTO…
MEDLINE INDUSTRIES, LP - Northfield
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Philips North America Llc
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Becton Dickinson & Co.
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Cartiva, Inc
MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L;…
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF…
MEDLINE INDUSTRIES, LP - Northfield
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Becton Dickinson & Co.
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
MEDLINE INDUSTRIES, LP - Northfield
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ8…
MEDLINE INDUSTRIES, LP - Northfield
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
Ziehm Vision system, x-ray, tomography, computed.
Orthoscan, Inc.
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
MEDLINE INDUSTRIES, LP - Northfield
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control min…
Advanced Medical Solutions Ltd.
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Becton Dickinson & Co.
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
GE Healthcare (China) Co., Ltd.
MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ…
MEDLINE INDUSTRIES, LP - Northfield
GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
GE Healthcare (China) Co., Ltd.
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PA…
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND …
MEDLINE INDUSTRIES, LP - Northfield
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
GE Healthcare (China) Co., Ltd.
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Orthoscan, Inc.
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Sieme…
Siemens Healthcare Diagnostics, Inc.
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4…
MEDLINE INDUSTRIES, LP - Northfield
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Becton Dickinson & Co.
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
Becton Dickinson & Co.
MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M;…
MEDLINE INDUSTRIES, LP - Northfield
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Olympus Corporation of the Americas
Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
Orthoscan, Inc.
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
GE Healthcare (China) Co., Ltd.
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.