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 799 of 822
5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens…
Biomerieux Inc
Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device…
Mindray DS USA, Inc. d.b.a. Mindray North America
. 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisi…
Zimmer, Inc.
Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quan…
Siemens Healthcare Diagnostics, Inc.
7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the br…
OrthoPediatrics Corp
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Software upda…
Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Softw…
Biomerieux Inc
BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is cl…
Kerr Corporation
INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatmen…
Carl Zeiss Meditec, Inc.
qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches -…
Spacelabs Healthcare, Llc
5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours o…
Terumo Cardiovascular Systems Corporation
EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC adm…
MOOG Medical Devices Group
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cot…
Progressive Medical Inc
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Cre…
Horiba Instruments, Inc dba Horiba Medical
Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient …
Gulf South Medical Supply Inc
HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled…
Terumo Cardiovascular Systems Corporation
Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature cont…
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours o…
Terumo Cardiovascular Systems Corporation
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventor…
Trivascular, Inc
PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewa…
Dako North America Inc.
ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood…
Zimmer, Inc.
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours o…
Terumo Cardiovascular Systems Corporation
Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component …
Stryker Howmedica Osteonics Corp.
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 ho…
Terumo Cardiovascular Systems Corporation
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures…
Synthes USA HQ, Inc.
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours o…
Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 ho…
Terumo Cardiovascular Systems Corporation
The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 …
Spacelabs Healthcare, Llc
Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw
Zimmer, Inc.
Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedure…
Sorin Group USA, Inc.
Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. …
Sysmex America, Inc.
Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Clinical Diagnostic Solutions
NCB¿ screw ¿ 4.0 self-tapping
Zimmer, Inc.
0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-…
Shimadzu Medical Systems
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femora…
Medacta Usa Inc
DTO" Implant
Zimmer, Inc.
Anatomical Shoulder" Fracture Humeral stem
Zimmer, Inc.
Alloclassic SL Shaft
Zimmer, Inc.
Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
Zimmer, Inc.
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system…
Shimadzu Medical Systems
0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who…
Shimadzu Medical Systems
S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedure…
Sorin Group USA, Inc.
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedur…
Sorin Group USA, Inc.
Biolox¿ Option Ceramic Femoral Head System Rx, sterile
Zimmer, 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.