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 · 2026-08-26
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 563 of 819
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component d…
Biomet 3i, LLC
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Inte…
Stanmore Implants Worldwide Ltd.
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if …
Stanmore Implants Worldwide Ltd.
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly co…
Biomet 3i, LLC
OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chamb…
Oscor, Inc.
Zeus-P Lumbar Interbody Device
Amendia, Inc
OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the heart chamb…
Oscor, Inc.
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly …
Biomet 3i, LLC
Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bo…
Amendia, Inc
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction of cat…
Oscor, Inc.
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, …
Teleflex Medical
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction of cathe…
Oscor, Inc.
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly …
Biomet 3i, LLC
OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart chamber…
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chamber…
Oscor, Inc.
Optimus Fixed Awl
Amendia, Inc
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…
Biomet 3i, LLC
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component d…
Biomet 3i, LLC
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic comp…
Biomet 3i, LLC
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart ch…
Oscor, Inc.
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, phar…
Teleflex Medical
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Num…
Amendia, Inc
8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous mater…
Stryker Instruments Div. of Stryker Corporation
PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, …
PerkinElmer, Inc
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…
Biomet 3i, LLC
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of cat…
Oscor, Inc.
AbbVie PEG Kit 20 FR
AbbVie Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065…
Angiodynamics, Inc.
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent…
Medtronic
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia…
Teleflex Medical
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Synthes (USA) Products LLC
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly …
Biomet 3i, LLC
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/E…
Owens & Minor Distribution, Inc.
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…
Biomet 3i, LLC
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart c…
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chamber…
Oscor, Inc.
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Teleflex Medical
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
PerkinElmer Health Sciences, Inc.
Ultroid Sterile Disposable Probes sold individually
Ultroid Technologies, Inc.
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chamb…
Oscor, Inc.
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog…
Siemens Healthcare Diagnostics, Inc.
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fu…
Medtronic Inc
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…
Biomet 3i, LLC
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of cath…
Oscor, Inc.
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with …
Philips Electronics North America Corporation
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 2423…
Stryker Howmedica Osteonics Corp.
8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseo…
Stryker Instruments Div. of Stryker Corporation
Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthc…
Ansell Healthcare Products LLC
FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray …
Teleflex Medical
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutane…
Nuvectra
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.