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
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 284 of 819
Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
Exact Medical Manufacturing, Inc.
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
Exact Medical Manufacturing, Inc.
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Pear Therapeutics, Inc.
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented …
Smith & Nephew, Inc.
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Cardinal Health Inc.
novaplus, General Purpose Kit, Cat. No. 56603
Medical Action Industries, Inc. 306
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Cardinal Health Inc.
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Cardinal Health Inc.
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Pear Therapeutics, Inc.
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
Exact Medical Manufacturing, Inc.
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Cardinal Health Inc.
VAPORIZER VICKS 1.5GAL Item Number: 2354942
Cardinal Health Inc.
inLight Medical LED Pads used with Polychromatic light technology system
Inlightened Partners LLC
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
Exact Medical Manufacturing, Inc.
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Exact Medical Manufacturing, Inc.
Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
Exact Medical Manufacturing, Inc.
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Philips Medical Systems Nederlands
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and g…
EHOB, Inc.
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
BioFire Diagnostics, LLC
Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
Medical Action Industries, Inc. 306
6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
Exact Medical Manufacturing, Inc.
Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
Medical Action Industries, Inc. 306
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
Exact Medical Manufacturing, Inc.
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
Cardinal Health Inc.
Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
Exact Medical Manufacturing, Inc.
BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
Cardinal Health Inc.
Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
Exact Medical Manufacturing, Inc.
Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
Medical Action Industries, Inc. 306
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
Beckman Coulter Inc.
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
Cardinal Health Inc.
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
GE Healthcare, LLC
AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
Cardinal Health Inc.
6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
Exact Medical Manufacturing, Inc.
FREESTYLE LANCETS 28G 100CT Item Number:2975670
Cardinal Health Inc.
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
Cardinal Health Inc.
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381…
BioFire Diagnostics, LLC
Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
Exact Medical Manufacturing, Inc.
Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
Exact Medical Manufacturing, Inc.
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Cardinal Health Inc.
Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220
Medical Action Industries, Inc. 306
QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou
World Source Llc
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care…
Covidien, LP
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Siemens Healthcare Diagnostics, Inc.
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respi…
Covidien, LP
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Corin Ltd
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
E3800 PC Units (spare parts)
Radiometer Medical ApS
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialy…
Medivators, Inc.
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
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.