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 582 of 819
Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
W & C dba The Apothecary
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other me…
Integra LifeSciences Corp. d.b.a. Integra Pain Management
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in a…
Abbott Medical Optics Inc. (AMO)
Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI…
Invivo Corporation
G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
The Anspach Effort, Inc.
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who w…
Smith & Nephew, Inc.
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration…
Hospira Inc.
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual correcti…
Abbott Medical Optics Inc. (AMO)
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Biomet 3i, LLC
LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
Hospira Inc.
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in a…
Abbott Medical Optics Inc. (AMO)
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult pa…
Abbott Medical Optics Inc. (AMO)
G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
The Anspach Effort, Inc.
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be use…
Ormco/Sybronendo
MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota,…
Global Healthcare Inc
McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image …
Mckesson Medical Imaging Group
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, an…
Siemens Medical Solutions USA, Inc
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6…
Trimed Inc
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, In…
CooperSurgical, Inc.
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both co…
OrthoPediatrics Corp
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a catar…
Abbott Medical Optics Inc. (AMO)
G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
The Anspach Effort, Inc.
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Carefusion 2200 Inc
G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
The Anspach Effort, Inc.
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of …
Abbott Medical Optics Inc. (AMO)
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both co…
OrthoPediatrics Corp
CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of m…
Merge Healthcare, Inc.
FPS 35mm x 3.5 mm non-locking screw
Ortho Solutions Inc
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embry…
CooperSurgical, Inc.
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication…
Siemens Medical Solutions USA, Inc
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and com…
Merge Healthcare, Inc.
St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to…
Sorin Group USA, Inc.
TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for the visu…
Abbott Medical Optics Inc. (AMO)
TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a catar…
Abbott Medical Optics Inc. (AMO)
Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-…
Pentax of America Inc
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
Carefusion 2200 Inc
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Philips Electronics North America Corporation
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
EKOS Corporation
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
Siemens Healthcare Diagnostics, Inc.
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation for the visual correction of …
Abbott Medical Optics Inc. (AMO)
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Hologic, Inc
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aph…
Abbott Medical Optics Inc. (AMO)
Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extra…
ICU Medical, Inc.
The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN …
Ortho-Clinical Diagnostics
Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a b…
Integra LifeSciences Corporation
Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 …
ICU Medical, Inc.
Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 1032123…
Siemens Healthcare Diagnostics Inc
Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressure Transduce…
ICU Medical, Inc.
Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
C.R. Bard, Inc.
Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item …
ICU Medical, 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.