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 801 of 822
Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total ho…
Siemens Healthcare Diagnostics, Inc.
MS-30¿ Proximal positioner
Zimmer, Inc.
Anatomical Shoulder" Fracture Humeral Head
Zimmer, Inc.
Metasul¿ LDH¿ Head Rx Sterile
Zimmer, Inc.
Biolox¿ delta Ceramic Femoral Head Rx only, sterile
Zimmer, Inc.
S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures …
Sorin Group USA, Inc.
Sunquest Laboratory, version 7.0 not available
Sunquest Information Systems, Inc.
Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
Zimmer, Inc.
MS-30 Shaft, Sterile, Rx
Zimmer, Inc.
Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at eith…
OrthoPediatrics Corp
The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit …
Kerr Corporation
Zimmer Inverse/Reverse Screw system,
Zimmer, Inc.
Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. W…
Sysmex America, Inc.
Anatomical Shoulder" Ball taper for humeral stem
Zimmer, Inc.
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery
Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Sunquest Information Systems, Inc.
Joss Rock Climbing Cam Units Recalled by Sierra Trading Post Due to a Fall Hazard; Sold Exclusively by Sierra Trading Post
Cassin Sri, of Italy
MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic pa…
Elekta, Inc.
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The Q…
Maquet Cardiovascular Us Sales, Llc
Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V1127…
Wright Medical Technology Inc
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The…
Ventlab Corporation
Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09…
Vital Images, Inc.
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmo…
Sorin Group USA, Inc.
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 B…
Roche Molecular Systems, Inc.
Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF…
Siemens Healthcare Diagnostics, Inc
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 Th…
Ventlab Corporation
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an ext…
Oscor, Inc.
V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. T…
Ventlab Corporation
HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Pr…
Heartsine Technologies, Limited
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is inte…
Ventlab Corporation
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cot…
Progressive Medical Inc
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to pro…
Ventlab Corporation
"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for …
Linvatec Corp. dba ConMed Linvatec
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators w…
Ventlab Corporation
Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X0…
Wright Medical Technology Inc
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypas…
Sorin Group USA, Inc.
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable…
Ventlab Corporation
ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis S…
Alphatec Spine, Inc.
Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. …
Ventlab Corporation
AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disp…
Ventlab Corporation
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen …
Focus Diagnostics Inc
Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C…
Wright Medical Technology Inc
Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
Ventlab Corporation
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Vent…
Ventlab Corporation
Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http:/…
Stryker Spine
ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image managem…
Varian Medical Systems, Inc. Oncology Systems
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators…
Ventlab Corporation
Bose Recalls Dual-Voltage CineMate II Home Theater Speaker Systems Due to Fire Hazard
Bose Corporation, of Framingham, Mass.
SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-c…
DePuy Mitek, Inc., a Johnson & Johnson Co.
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-…
Westmed 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.