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 · 2026-08-29
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 625 of 819
AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. …
Stryker Spine
EndoVive 3s Low Profile Balloon Kits Part Number: M00549410 (XMD P/N 70-0050-B22) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548470 (XMD P/N 70-0050-E14) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes…
Zimmer Biomet, Inc.
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records …
Gsi Group Inc
EndoVive 3s Low Profile Balloon Kits Part Number: MM00548410 (XMD P/N 70-0050-814) The EndoVive 3s Low Profile Balloon is intended to provide gas…
Xeridiem Mediem Medical Devices Inc
Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics Corp.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548680 (XMD P/N 70-0050-318) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548950 (XMD P/N 70-0050-E20) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548650 (XMD P/N 70-0050-G16) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548830 (XMD P/N 70-0050-220) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549570 (XMD P/N 70-0050-D24) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548850 (XMD P/N 70-0050-420) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549390 (XMD P/N 70-0050-922) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548560 (XMD P/N 70-0050-716) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD P/N 70-0050-A18)
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548920 (XMD P/N 70-0050-B20) The EndoVive 3s Low Profile Balloon is intended to provide gast…
Xeridiem Mediem Medical Devices Inc
United Pet Group Recalls Top Fin Power Filters for Aquariums Due to Shock Hazard; Sold Exclusively at PetSmart
United Pet Group, of Earth City, Mo.
Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra Universal Sho…
Medtronic
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anes…
CareFusion 303, Inc.
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development …
Lab Vision Corporation
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electr…
Nihon Kohden America Inc
REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Produc…
C.R. Bard, Inc.
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Ecl…
Varian Medical Systems, Inc.
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with …
Philips Electronics North America Corporation
High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
Smith & Nephew, Inc., Endoscopy Div.
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use stat…
Leica Microsystems, Inc.
Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra …
Medtronic
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed…
Sorin Group USA, Inc.
GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope tha…
Verathon, Inc.
LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
Smith & Nephew, Inc.
Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Univers…
Medtronic
EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microp…
Bio-Rad Laboratories, Inc.
Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Unive…
Medtronic
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Viewray Incorporated
Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer Syste…
Exactech, Inc.
IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: Zimmer Dental implant systems are designed for use in the …
Zimmer Dental Inc
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diag…
Philips Electronics North America Corporation
MEVION S250 Radiation therapy system
Mevion Medical Systems, Inc.
IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: Zimmer Dental implant systems are designed for use in the maxi…
Zimmer Dental Inc
GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
GE Medical Systems, LLC
Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use d…
Richard Wolf Medical Instruments Corp.
Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device int…
Richard Wolf Medical Instruments Corp.
Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, …
Biomet France SARL
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessel…
Bard Peripheral Vascular Inc
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/…
Orthofix, Inc
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
C.R. Bard, Inc.
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Toshiba American Medical Systems Inc
IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: Zimmer Dental implant systems are designed for use in the max…
Zimmer Dental 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.