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
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 367 of 819
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated …
Exactech, Inc.
JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood sh…
Haemonetics Corporation
2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver si…
Synthes, Inc.
SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolu…
GE Healthcare, LLC
GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a res…
Collagen Matrix Inc
LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION A…
Smith & Nephew, Inc.
VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485
Vitreq Bv
GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable…
Collagen Matrix Inc
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Arthrex, Inc.
Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal…
Brasseler USA I Lp
GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable…
Collagen Matrix Inc
Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subs…
Haemonetics Corporation
VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
Vitreq Bv
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, cli…
Siemens Healthcare Diagnostics, Inc.
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve sti…
LivaNova USA Inc
VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522
Vitreq Bv
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resoluti…
GE Healthcare, LLC
SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resoluti…
GE Healthcare, LLC
Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introduce…
Bard Peripheral Vascular Inc
CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed d…
Haemonetics Corporation
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated f…
Exactech, Inc.
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-…
Beckman Coulter Inc.
(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188
Vitreq Bv
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver si…
Synthes, Inc.
VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
Vitreq Bv
CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood she…
Haemonetics Corporation
CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processi…
Haemonetics Corporation
Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 …
Medline Industries Inc
Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14
Johnson & Johnson Surgical Vision Inc
VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607
Vitreq Bv
CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery …
Haemonetics Corporation
VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
Vitreq Bv
RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
RAYSEARCH LABORATORIES AB
GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable…
Collagen Matrix Inc
GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resor…
Collagen Matrix Inc
EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the D…
Energetiq Technology Inc
JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to a…
Haemonetics Corporation
Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood sh…
Haemonetics Corporation
BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (fron…
Mindray DS USA, Inc. dba Mindray North America
2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver si…
Synthes, Inc.
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Custom Healthcare Systems, Inc.
VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645
Vitreq Bv
CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery …
Haemonetics Corporation
ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical i…
Zimmer Biomet, Inc.
VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461
Vitreq Bv
CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed d…
Haemonetics Corporation
Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stim…
LivaNova USA Inc
SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonan…
GE Healthcare, LLC
High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery…
Haemonetics Corporation
JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent …
Haemonetics Corporation
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.