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 573 of 819
TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 713220…
Smith & Nephew, Inc.
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The pa…
Medtronic Navigation, Inc.
Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tole…
Azer Scientific, Inc.
Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended …
Stryker Neurovascular
Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended …
Stryker Neurovascular
Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended t…
Stryker Neurovascular
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packa…
Medtronic Navigation, Inc.
TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 7…
Smith & Nephew, Inc.
Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intende…
Stryker Neurovascular
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional …
Battle Creek Equipment Co.
TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Par…
Mindray DS USA, Inc. dba Mindray North America
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood he…
Maquet Cardiovascular Us Sales, Llc
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/1…
Unomedical As
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; …
Unomedical As
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Co…
Unomedical As
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data…
Spacelabs Healthcare Inc
Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OG…
Azer Scientific, Inc.
Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are in…
Stryker Neurovascular
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; S…
Unomedical As
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gar…
Arrow International Inc
Rigid Suction Canister 3000 CC and 2000 CC.
Medline Industries Inc
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anestheti…
Epimed International, Inc.
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silho…
Unomedical As
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a ho…
Stryker Sustainability Solutions
Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended …
Stryker Neurovascular
Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to…
Stryker Neurovascular
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
Hospira Inc.
Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are int…
Stryker Neurovascular
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Encore Medical, Lp
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and L…
Hill-Rom, Inc.
Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to…
Stryker Neurovascular
Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended …
Stryker Neurovascular
Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional an…
B. Braun Medical, Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
Hospira Inc.
Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intend…
Stryker Neurovascular
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort…
Unomedical As
Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are inten…
Stryker Neurovascular
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devi…
Sequent Medical Inc
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pa…
TEM Systems Inc
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Mo…
Roche Diagnostics Operations, Inc.
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Aesculap Implant Systems LLC
cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a compute…
Roche Diagnostics Operations, Inc.
cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automate…
Roche Diagnostics Operations, Inc.
VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated, random acce…
Roche Diagnostics Operations, Inc.
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy…
Pentax of America Inc
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral arte…
AccessClosure, Inc., A Cardinal Health Company
da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instr…
Intuitive Surgical, Inc.
URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sortin…
Roche Diagnostics Operations, Inc.
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique …
Siemens Healthcare Diagnostics, Inc.
PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity o…
Becton Dickinson & Co.
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.