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
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 256 of 819
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Lacrimedics Inc
BUTLER Clear Dip, 12 bottles/case
Sunstar Americas, Inc.
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expo…
Hobbs Medical, Inc.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
BioPro, Inc.
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized …
Microbiologics Inc
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
ROi CPS LLC
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pa…
Microbiologics Inc
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
CELLTRION USA INC
QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived fro…
Microbiologics Inc
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
CELLTRION USA INC
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Beckman Coulter Inc.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
BioPro, Inc.
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
BioPro, Inc.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
BioPro, Inc.
Everest MI XT Outer Dilator, Catalog Number 5101-90168
K2M, Inc
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
BioPro, Inc.
Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
Microbiologics Inc
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
Lacrimedics Inc
Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
Brasseler USA, Medical L.L.C.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
BioPro, Inc.
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Orthosoft, Inc. dba Zimmer CAS
LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
Microbiologics Inc
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Stryker Leibinger GmbH & Co. KG
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
Microbiologics Inc
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
Shimadzu Medical Systems
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
C.R. Bard Inc
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
C.R. Bard Inc
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a t…
Becton Dickinson & Company
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hyp…
BALT USA, LLC
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF…
Medtronic Vascular, Inc.
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
Biomet, Inc.
Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
Biomet, Inc.
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632
Biomet, Inc.
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
Biomet, Inc.
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Nobel Biocare Usa Llc
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Collagen Matrix, Inc.
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
Biomet, Inc.
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
Biomet, Inc.
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Stryker Sustainability Solutions
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qu…
MEDLINE INDUSTRIES, LP - Northfield
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Collagen Matrix, Inc.
Michels Transport Medium, 20ML Prefilled Cont
MEDLINE INDUSTRIES, LP - Northfield
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
Biomet, Inc.
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
Biomet, Inc.
Fitbit Recalls Ionic Smartwatches Due to Burn Hazard; One Million Sold in the U.S.
Petzl Recalls PIRANA Descender Canyoneering Devices Due to Drowning Risk
HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-010…
STAQ Pharma, Inc.
Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0105-0…
STAQ Pharma, Inc.
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percu…
TELEFLEX 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.