Product category · Updated Aug 19, 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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.
- 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.
- 41,070
- 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
41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-04
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 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 816 of 822
Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred t…
Alere San Diego, Inc.
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the …
superDimension, Inc
Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte.…
Argon Medical Devices, Inc
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or…
Civco Medical Instruments Inc
Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US an…
Arjo, Inc. dba ArjoHuntleigh
Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the …
Terumo Cardiovascular Systems Corporation
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infan…
Atom Medical Corporation
Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to…
Edwards Lifesciences, LLC
System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood fo…
Terumo Cardiovascular Systems Corporation
iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, …
Abbott Point Of Care Inc.
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. …
Civco Medical Instruments Inc
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument…
Civco Medical Instruments Inc
Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment o…
Integra LifeSciences Corp
Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21…
Arjo, Inc. dba ArjoHuntleigh
System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood …
Terumo Cardiovascular Systems Corporation
Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and cli…
Philips Medical Systems (Cleveland) Inc
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is pa…
PSC Industries Inc
Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and da…
Philips Healthcare Inc.
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other me…
Integra LifeSciences Corp. d.b.a. Integra Pain Management
LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were package…
DePuy Orthopaedics, Inc.
Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Sid…
DePuy Mitek, Inc., a Johnson & Johnson Co.
LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged …
DePuy Orthopaedics, Inc.
LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were package…
DePuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Fo…
DePuy Orthopaedics, Inc.
LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were package…
DePuy Orthopaedics, Inc.
AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, …
Carefusion 2200 Inc
ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foa…
DePuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foa…
DePuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foa…
DePuy Orthopaedics, Inc.
LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packag…
DePuy Orthopaedics, Inc.
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkw…
Carefusion 2200 Inc
ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Fo…
DePuy Orthopaedics, Inc.
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacue…
Greiner Bio-One North America, Inc.
LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were package…
DePuy Orthopaedics, Inc.
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during…
Aesculap Implant Systems LLC
Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.
Pride Mobility Products Corp
LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were package…
DePuy Orthopaedics, Inc.
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, …
Carefusion 2200 Inc
ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Fo…
DePuy Orthopaedics, Inc.
TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S…
Invacare Corporation
Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is …
DePuy Mitek, Inc., a Johnson & Johnson Co.
LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were package…
DePuy Orthopaedics, Inc.
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is …
DePuy Mitek, Inc., a Johnson & Johnson Co.
ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Fo…
DePuy Orthopaedics, Inc.
Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side…
DePuy Mitek, Inc., a Johnson & Johnson Co.
ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Fo…
DePuy Orthopaedics, Inc.
LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were package…
DePuy Orthopaedics, Inc.
ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foa…
DePuy Orthopaedics, Inc.
AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm…
Thayer Medical Corporation
Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Em…
Microbiologics 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 Aug 19, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.