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 · 2026-08-24
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 498 of 819
LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only Product Usage: The LaserEdge Kniv…
Bausch & Lomb Inc Irb
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is…
Euro Diagnostica AB
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT CODE E7575, STERILE, Rx Only Product Usage: The LaserEdge Knives are intende…
Bausch & Lomb Inc Irb
LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knives are…
Bausch & Lomb Inc Irb
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is int…
Philips Electronics North America Corporation
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch…
Steris Corporation
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Cosmedent, Inc.
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of t…
Integra LifeSciences Corp.
Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 772…
Siemens Medical Solutions USA, Inc
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as ancho…
Keystone Dental Inc
STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Con…
ConMed Corporation
AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
Avid Medical, Inc.
AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02
Avid Medical, Inc.
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
Ventana Medical Systems Inc
Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…
Steris Corporation
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Ethicon, Inc.
AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
Avid Medical, Inc.
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feed…
Cook Inc.
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
Aesculap Implant Systems LLC
AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the im…
Howmedica Osteonics Corp.
Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…
Steris Corporation
Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Siemens Medical Solutions USA, Inc
A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 14…
Olympus Corporation of the Americas
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
Ventana Medical Systems Inc
Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…
Steris Corporation
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
Ventana Medical Systems Inc
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
Ventana Medical Systems Inc
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…
Steris Corporation
Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouc…
Steris Corporation
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacemen…
DePuy Orthopaedics, Inc.
Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correc…
CooperVision Inc.
14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
Zimmer Biomet, Inc.
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…
Steris Corporation
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Cat…
Angiodynamics, Inc.
AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02
Avid Medical, Inc.
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…
Steris Corporation
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
Ventana Medical Systems Inc
Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouc…
Steris Corporation
Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Cook Inc.
ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
Ventana Medical Systems Inc
Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
Teleflex Medical
Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…
Steris Corporation
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -00842768013102471842…
Siemens Healthcare Diagnostics
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional…
Siemens Medical Solutions USA, Inc
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…
Steris Corporation
Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…
Steris Corporation
AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01
Avid Medical, Inc.
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouc…
Steris Corporation
Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pou…
Steris Corporation
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archivi…
Trumpf Medical Systems, 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.