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
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
40,910 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 · NHTSA federal recall filings · 2026-08-25
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 538 of 819
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is design…
MEDLINE INDUSTRIES INC
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprot…
Beckman Coulter Inc.
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Ziehm Imaging Inc
ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of i…
Siemens Healthcare Diagnostics, Inc
GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0;…
Aesculap Implant Systems LLC
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Mat…
Respironics California Inc
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Magellan Diagnostics, Inc.
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly t…
Vortran Medical Technology 1, Inc
SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into th…
Bausch & Lomb Surgical, Inc.
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasm…
Beckman Coulter Inc.
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of…
BioMerieux SA
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is de…
MEDLINE INDUSTRIES INC
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250,…
Sorin Group Italia SRL - CRF
Navitrack System - OS Knee Universal, Stereotaxic instrument
Orthosoft, Inc. dba Zimmer CAS
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is design…
MEDLINE INDUSTRIES INC
NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08…
Abbott Vascular
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Pa…
Medtest Holdings, Inc.
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is d…
MEDLINE INDUSTRIES INC
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Zimmer Biomet, Inc.
INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, …
Sorin Group Italia SRL - CRF
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO White…
Abbott Medical Optics Inc. (AMO)
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
Biomet Microfixation, LLC
GIZA Vertebral Body Replacement
Eden Spine Europe SA
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
Siemens Healthcare Diagnostics, Inc
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,…
Aesculap Implant Systems LLC
Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides concentration in human serum or p…
Beckman Coulter Inc.
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T,…
Abbott Vascular
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasm…
Beckman Coulter Inc.
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
Hitachi Medical Systems America Inc
White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in v…
Medical Action Industries Inc
PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVAT…
Sorin Group Italia SRL - CRF
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients …
Ion Beam Applications S.A.
VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to …
Vortran Medical Technology 1, Inc
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is d…
MEDLINE INDUSTRIES INC
ARIES System and ARIES M1 System
Luminex Corporation
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
ReFlow Medical
Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally…
Medical Action Industries Inc
Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebro…
Beckman Coulter Inc.
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
Ortho-Clinical Diagnostics
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assemb…
Del Mar Reynolds Medical, Ltd.
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radia…
Mobius Medical Systems, LP
NDI P7 Position Sensor, Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Arthrex, Inc.
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gase…
Siemens Healthcare Diagnostics Inc
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Arthrex, Inc.
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Abbott Medical Optics Inc. (AMO)
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guid…
Stryker Instruments Div. of Stryker Corporation
Healon Pro, Part No. 10270012
Abbott Medical Optics Inc. (AMO)
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux …
Mederi Therapeutics, Inc
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.