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 592 of 819
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Hitachi Medical Systems America Inc
Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281,…
Siemens Medical Solutions USA, Inc
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
Integra LifeSciences Corp.
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", …
Nobel Biocare Usa Llc
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -…
ORTHO-CLINICAL DIAGNOSTICS
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium…
Becton, Dickinson and Company, BD Biosciences
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Philips Medical Systems (Cleveland) Inc
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter f…
Stryker Howmedica Osteonics Corp.
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Rece…
Synthes (USA) Products LLC
Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080…
Hill-Rom, Inc.
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Philips Medical Systems (Cleveland) Inc
Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmi…
Philips Medical Systems (Cleveland) Inc
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three…
Merge Healthcare, Inc.
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Zimmer Biomet Spine, Inc
Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ra…
Philips Medical Systems (Cleveland) Inc
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Zimmer Biomet Spine, Inc
lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare…
Invacare Corporation
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and …
Intuitive Surgical, Inc.
Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic us…
Siemens Healthcare Diagnostics Inc
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
C.R. Bard, Inc.
Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and …
Invacare Corporation
MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
Philips Medical Systems (Cleveland) Inc
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
Philips Medical Systems (Cleveland) Inc
OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol As…
Ivoclar Vivadent, Inc.
Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transm…
Philips Medical Systems (Cleveland) Inc
NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction s…
BioMerieux SA
Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable …
Stryker Howmedica Osteonics Corp.
STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 …
Intuitive Surgical, Inc.
Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
Philips Medical Systems (Cleveland) Inc
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Mon…
Edan Diagnostics
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circui…
Draeger Medical, Inc.
AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (…
Beckman Coulter Inc.
V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Zimmer Gmbh
Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures i…
Teleflex Medical
AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid det…
Branan Medical Corporation
Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product label is ap…
Zimmer Surgical Inc
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usa…
Medtronic Navigation, Inc.
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to …
AccessClosure, Inc., A Cardinal Health Company
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/…
Spacelabs Healthcare Inc
Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiatio…
Olympus Scientific Solutions Americas
RePlant¿ Angled Abutment Part Number 6050-52-60
Implant Direct Sybron Manufacturing, LLC
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The…
Medtronic Navigation, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dime…
Merge Healthcare, Inc.
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM V…
Roche Diagnostics Operations, Inc.
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Us…
Medtronic Navigation, Inc.
Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged insid…
Zimmer Surgical Inc
Merge HEMO software.
Merge Healthcare, Inc.
Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inside of a padded-foam corrugate box. A product l…
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label i…
Zimmer Surgical 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.