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 594 of 819
Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge conta…
LeMaitre Vascular, Inc.
Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
The Metrix Company
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy …
Pentax Medical Company
AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge cont…
LeMaitre Vascular, Inc.
Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 I…
Moller Vital
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selec…
Alere San Diego, Inc.
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the pac…
Tosoh Bioscience, Inc.
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of …
Siemens Healthcare Diagnostics, Inc.
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy inclu…
Pentax Medical Company
Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively an…
Alere San Diego, Inc.
Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier…
LeMaitre Vascular, Inc.
GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
GE Inspection Technologies, LP
Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and s…
Alere San Diego, Inc.
Container fill and transfer sets, 250 mL and 500 mL, . .
The Metrix Company
AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge contai…
LeMaitre Vascular, Inc.
Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro D…
Beckman Coulter Inc.
Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL
The Metrix Company
Endotine Transbleph 3.5 (CFD-080-0167)
MicroAire Surgical Instruments, LLC
AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge contai…
LeMaitre Vascular, Inc.
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by …
Ge Healthcare It
Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented pro…
Zimmer Gmbh
Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy …
Pentax Medical Company
VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales U…
Ortho-Clinical Diagnostics
Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
The Anspach Effort, Inc.
T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a cont…
WalkMed Infusion, LLC
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
WalkMed Infusion, LLC
Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an …
Terumo Cardiovascular Systems Corporation
Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measure…
CSL Behring GmbH
2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, No…
Stryker Instruments Div. of Stryker Corporation
T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product U…
WalkMed Infusion, LLC
T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids…
WalkMed Infusion, LLC
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
WalkMed Infusion, LLC
T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container…
WalkMed Infusion, LLC
cobas¿ Liat¿ Analyzer
Roche Molecular Systems, Inc.
Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET…
Centurion Medical Products Corporation
Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat …
Terumo Cardiovascular Systems Corporation
T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Pro…
WalkMed Infusion, LLC
Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
Smith & Nephew, Inc.
T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from…
WalkMed Infusion, LLC
Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I ex…
Synthes (USA) Products LLC
T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from …
WalkMed Infusion, LLC
BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
Becton, Dickinson and Company, BD Biosciences
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgica…
Nobel Biocare Usa Llc
Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion …
Bayer Healthcare
HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent water circuit…
Terumo Cardiovascular Systems Corporation
T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: U…
WalkMed Infusion, LLC
T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer f…
WalkMed Infusion, LLC
T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from …
WalkMed Infusion, LLC
Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchang…
Terumo Cardiovascular Systems Corporation
OT1000 Series Orthopedic Surgical Tables
Steris 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.