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 212 of 819
Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
MEDLINE INDUSTRIES, LP - Northfield
Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
MEDLINE INDUSTRIES, LP - Northfield
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the…
Universal Meditech Inc.
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Comp…
Smiths Medical ASD Inc.
(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee Sy…
Biomet, Inc.
GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SY…
Pharmacy Innovations
BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Pharmacy Innovations
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Pharmacy Innovations
HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Pharmacy Innovations
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 501…
SunMed Holdings, LLC
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Meridian Bioscience Inc
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal…
TELEFLEX LLC
Getinge Flow-e Anesthesia System, Part No. 6887900
Getinge Usa Sales Inc
FUSION Dual Pump Packs, REF: OPO73
Johnson & Johnson Surgical Vision, Inc.
Getinge Flow-c Anesthesia System, Part No. 6887700
Getinge Usa Sales Inc
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Getinge Usa Sales Inc
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibi…
Biomet, Inc.
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Future Diagnostics Solutions B.V.
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Comput…
Siemens Medical Solutions USA, Inc
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
TELEFLEX LLC
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Align Technology Inc
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
CooperVision, Inc.
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplificati…
Abbott Molecular, Inc.
Veritas Advanced Infusion Packs, REF: VRT-AI
Johnson & Johnson Surgical Vision, Inc.
Single-Use Packs, REF: OPO80
Johnson & Johnson Surgical Vision, Inc.
biokitHSV-2 Rapid Test, REF: 300028001
Biokit, S.A.
CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
MEDLINE INDUSTRIES, LP - Northfield
Agfa HealthCare Enterprise Imaging XERO Viewer
Agfa Healthcare NV
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 …
SunMed Holdings, LLC
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral…
TELEFLEX LLC
Baxter Electrocardiograph, ELI 380 -DCS21
Baxter Healthcare Corporation
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Siemens Medical Solutions USA, Inc
Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
Cardinal Health 200, LLC
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Siemens Medical Solutions USA, Inc
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
Cardinal Health 200, LLC
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Abbott Laboratories
R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hemat…
R & D Systems, Inc.
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230
Cardinal Health 200, LLC
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
Bolton Medical Inc.
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Mobius Imaging, LLC
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.