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 428 of 819
Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Phoenix AST Indicator, Catalog Number 246004
Becton Dickinson & Co.
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Siemens Medical Solutions USA, Inc
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care resp…
Physio-Control Inc
Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contami…
ICU Medical, Inc.
Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Phoenix AP AST Indicator Bag, Catalog Number 246006
Becton Dickinson & Co.
Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Arrow International Inc
Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST…
Organon Teknika Inc
Phoenix AST-s Indicator, Catalog Number 246009
Becton Dickinson & Co.
Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Terumo Cardiovascular Systems Corporation
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal I…
Merge Healthcare, Inc.
Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
Zimmer Biomet, Inc.
AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Arrow International Inc
Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump
Arrow International Inc
AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Arrow International Inc
Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging System
Philips Medical Systems Nederlands
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avel…
Advanced Pharma Inc.
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308…
US Compounding Inc
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Randox Laboratories Ltd.
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, m…
Smiths Medical ASD Inc.
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric pati…
Philips North America, LLC
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric pati…
Philips North America, LLC
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4…
Smiths Medical ASD Inc.
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment …
Baxter Healthcare Corporation
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.