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 487 of 819
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for …
Cook Inc.
Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in sup…
Keystone Dental Inc
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
OraSure Technologies, Inc.
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circui…
Teleflex Medical Europe Ltd
Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Terumo Cardiovascular Systems Corporation
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sec…
Philips Medical Systems (Cleveland) Inc
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperatu…
Terumo Cardiovascular Systems Corporation
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloadi…
Stryker Medical Division of Stryker Corporation
Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produc…
Philips Medical Systems (Cleveland) Inc
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloa…
Getinge Disinfection Ab
Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera…
Philips Electronics North America Corporation
T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spect…
Philips Electronics North America Corporation
ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation…
Siemens Medical Solutions USA, Inc
ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for…
Siemens Medical Solutions USA, Inc
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The T…
TMJ Solutions Inc
Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission …
Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-…
Philips Medical Systems (Cleveland) Inc
JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
Carefusion 2200 Inc
Manometer, 550 ml three-Way Stopcock; STERILE;
Carefusion 2200 Inc
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
Wright Medical Technology, Inc.
ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for …
Siemens Medical Solutions USA, Inc
GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734,…
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS261…
Draegar Medical Systems, Inc.
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Life Technologies Corporation
Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to …
Philips Medical Systems (Cleveland) Inc
ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or s…
Philips Electronics North America Corporation
Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspi…
Cook Inc.
Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (…
Mindray DS USA, Inc. dba Mindray North America
Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 65070416…
Teleflex Medical Europe Ltd
Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are inten…
C.R. Bard, Inc.
(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Cat…
Arrow International Inc
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS,…
ICU Medical, Inc.
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
W & H DentalWerk Burmoos GMBH - Site 1
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ …
Arrow International Inc
VITROS Immunodiagnostic Products TSH Reagent Pack
Clinical Diagnostic Systems
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCRE…
Smith & Nephew, Inc.
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Orthofix, Inc
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
Ethicon, Inc.
IntelliVue X3 Patient Monitor.
Philips Electronics North America Corporation
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. …
ICU Medical, Inc.
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow T…
Arrow International Inc
ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) P…
Arrow International Inc
AUTO REF/KERATOMETER ARK-1s
Nidek Inc.
(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard B…
Arrow International Inc
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Hamilton Medical AG
VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961…
GETINGE US SALES LLC
5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name o…
ICU Medical, Inc.
Strauss Penis Clamp 130MM/General Instruments
Aesculap Implant Systems LLC
Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intend…
C.R. Bard, 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.