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 · 2026-08-23
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 472 of 819
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC
Sun Med, LLC
The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, accord…
BioMerieux SA
RS 5F DL XCELA PICC, Catalog Number 60M122272
Angiodynamics Inc. (Navilyst Medical Inc.)
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
Philips Electronics North America Corporation
Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram met…
BioMerieux SA
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C
Sun Med, LLC
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
Sun Med, LLC
BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019
Angiodynamics Inc. (Navilyst Medical Inc.)
TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
Angiodynamics Inc. (Navilyst Medical Inc.)
Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
Angiodynamics Inc. (Navilyst Medical Inc.)
RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196
Angiodynamics Inc. (Navilyst Medical Inc.)
BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038
Angiodynamics Inc. (Navilyst Medical Inc.)
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Zimmer Biomet, Inc.
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P
Sun Med, LLC
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
Philips Electronics North America Corporation
RS 5F DL XPP, Catalog Number 60M030393
Angiodynamics Inc. (Navilyst Medical Inc.)
Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
The Seaberg Company Inc
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
Angiodynamics Inc. (Navilyst Medical Inc.)
BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033
Angiodynamics Inc. (Navilyst Medical Inc.)
RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097
Angiodynamics Inc. (Navilyst Medical Inc.)
Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiop…
Maquet Cardiopulmonary Ag
RS 5F DL BIOFLO PASV, Catalog Number 60M161567
Angiodynamics Inc. (Navilyst Medical Inc.)
STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
Sun Med, LLC
Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901
Angiodynamics Inc. (Navilyst Medical Inc.)
Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
Orthofix, Inc
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infus…
Baxter Healthcare Corporation
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / directio…
Draeger Medical Systems, Inc.
ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
Tosoh Bioscience Inc
Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
Orthofix, Inc
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images…
GE Healthcare
ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
Tosoh Bioscience Inc
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hex…
Orthofix Srl
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Randox Laboratories
L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
Orthofix, Inc
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
Tosoh Bioscience Inc
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated t…
Fresenius Medical Care Renal Therapies Group, LLC
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
Tosoh Bioscience Inc
ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
Tosoh Bioscience Inc
ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
Tosoh Bioscience Inc
Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
Orthofix, Inc
ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
Tosoh Bioscience Inc
ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
Tosoh Bioscience Inc
3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of …
Stryker Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Sp…
Baxter Healthcare Corporation
ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
Tosoh Bioscience Inc
ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
Tosoh Bioscience Inc
ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
Tosoh Bioscience Inc
ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
Tosoh Bioscience Inc
Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
C.R. Bard, Inc.
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient throu…
CareFusion 303, 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.