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 · 2026-08-27
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 583 of 819
AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft …
Howmedica Osteonics Corp.
Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient…
ICU Medical, Inc.
Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrav…
ICU Medical, Inc.
RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
Siemens Healthcare Diagnostics Inc
Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Mac…
ICU Medical, Inc.
Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
Arrow International Inc
Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrav…
ICU Medical, Inc.
SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrava…
ICU Medical, Inc.
5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular …
ICU Medical, Inc.
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Arrow International Inc
Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital me…
Siemens Medical Solutions USA, Inc
Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The Tra…
ICU Medical, Inc.
Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
Arrow International Inc
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1…
Hospira Inc., A Pfizer Company
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact w…
Circulatory Technology Inc
CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an unde…
Mentor Texas, LP.
Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66 …
ICU Medical, Inc.
Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tiss…
Stryker Howmedica Osteonics Corp.
Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable …
ICU Medical, Inc.
Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 46110-07 Us…
ICU Medical, Inc.
RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
Siemens Healthcare Diagnostics Inc
Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: …
ICU Medical, Inc.
Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is …
ICU Medical, Inc.
Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
Siemens Healthcare Diagnostics Inc
Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 Usage: The…
ICU Medical, Inc.
Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is…
ICU Medical, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macro…
ICU Medical, Inc.
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an anteg…
Stryker Howmedica Osteonics Corp.
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac Dis…
ICU Medical, Inc.
LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics syst…
Alere San Diego, Inc.
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Nav…
Biosense Webster, Inc.
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument…
Stryker Howmedica Osteonics Corp.
Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Macrodrip (Pol…
ICU Medical, Inc.
VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the d…
Biomerieux France Chemin De L'Or
Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is a…
ICU Medical, Inc.
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
C.R. Bard, Inc.
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an un…
Mentor Texas, LP.
TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight …
ICU Medical, Inc.
Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and qu…
Thermo Finnigan LLC
LAUREATE World Phaco System
Alcon Research, Ltd.
AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters …
AirStrip Technologies, Inc.
Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is …
ICU Medical, Inc.
Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
Siemens Healthcare Diagnostics Inc
Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous acce…
Arrow International Inc
RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
Siemens Healthcare Diagnostics Inc
Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the…
Sysmex America Inc
T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance…
T2 Biosystems Inc
Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 103313…
Siemens Healthcare Diagnostics 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.