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 · 2026-08-21
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 437 of 819
Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLIS…
GE Healthcare, LLC
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Stryker Medical Division of Stryker Corporation
Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provid…
Zimmer Biomet, Inc.
ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for s…
Siemens Medical Solutions USA, Inc
Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provid…
Zimmer Biomet, Inc.
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic t…
Siemens Healthcare Diagnostics, Inc.
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
AROA Biosurgery, LTD.
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT EN…
GE Healthcare, LLC
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: T…
Arrow International Inc
GE Healthcare Millennium MC
GE Healthcare, LLC
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, p…
Zimmer Biomet, Inc.
ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed fo…
Siemens Medical Solutions USA, Inc
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
AROA Biosurgery, LTD.
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
GE Healthcare, LLC
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH…
GE Healthcare, LLC
Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, pr…
Zimmer Biomet, Inc.
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
AROA Biosurgery, LTD.
OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
AROA Biosurgery, LTD.
Heron toilet and bath chair Model 880505-01 & 880505-11
R82 A/S
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
AROA Biosurgery, LTD.
OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
AROA Biosurgery, LTD.
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape,…
Covidien LLC
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the …
Siemens Healthcare Diagnostics, Inc.
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
AROA Biosurgery, LTD.
Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, p…
Zimmer Biomet, Inc.
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumenta…
Arthrex, Inc.
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simulta…
Luminex Corporation
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
GE Healthcare, LLC
OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
AROA Biosurgery, LTD.
OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
AROA Biosurgery, LTD.
OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
AROA Biosurgery, LTD.
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system develope…
Siemens Medical Solutions USA, Inc
OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
AROA Biosurgery, LTD.
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac str…
Stryker Sustainability Solutions
OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
AROA Biosurgery, LTD.
Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provid…
Zimmer Biomet, Inc.
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses …
Johnson & Johnson Surgical Vision Inc
OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
AROA Biosurgery, LTD.
OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
AROA Biosurgery, LTD.
bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
bioMerieux, Inc.
RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures …
Virtual Imaging, Inc.
OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
AROA Biosurgery, LTD.
Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provid…
Zimmer Biomet, Inc.
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
Stryker Medical Division of Stryker Corporation
Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provid…
Zimmer Biomet, Inc.
OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
AROA Biosurgery, LTD.
OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
AROA Biosurgery, LTD.
-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)0…
BioFire Diagnostics, LLC
AIA-900 Analyzer, Product code 022930, 022930R
Tosoh Bioscience Inc
OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
AROA Biosurgery, LTD.
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.