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 301 of 819
PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.
Aomori Olympus Co., Ltd.
KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency…
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
Aomori Olympus Co., Ltd.
B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pa…
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
Aomori Olympus Co., Ltd.
Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier pro…
Cardinal Health 200, LLC
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…
Aomori Olympus Co., Ltd.
PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA,…
Prytime Medical Devices, Inc.
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
Aomori Olympus Co., Ltd.
NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory …
Aomori Olympus Co., Ltd.
KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency c…
Aomori Olympus Co., Ltd.
NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine…
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
Aomori Olympus Co., Ltd.
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor…
GE Healthcare, LLC
Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
Cardinal Health 200, LLC
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascul…
ICU Medical, Inc.
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal …
Argon Medical Devices, Inc
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…
Aomori Olympus Co., Ltd.
NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
Aomori Olympus Co., Ltd.
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.…
Cook Inc.
EMBLEM S-ICD Model A209
Boston Scientific Corporation
NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
Aomori Olympus Co., Ltd.
K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 6MM, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
Aomori Olympus Co., Ltd.
Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide …
Cardinal Health 200, LLC
ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
Cardinal Health 200, LLC
K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Aomori Olympus Co., Ltd.
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal …
Argon Medical Devices, Inc
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…
Aomori Olympus Co., Ltd.
KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency…
Aomori Olympus Co., Ltd.
MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
Aomori Olympus Co., Ltd.
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
DePuy Orthopaedics, Inc.
INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
Aomori Olympus Co., Ltd.
SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive …
Aomori Olympus Co., Ltd.
K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Aomori Olympus Co., Ltd.
PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Aomori Olympus Co., Ltd.
Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier prot…
Cardinal Health 200, LLC
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Sti…
Argon Medical Devices, Inc
NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…
Aomori Olympus Co., Ltd.
K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Aomori Olympus Co., Ltd.
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
Cardinal Health 200, LLC
INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
Aomori Olympus Co., Ltd.
B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the …
Aomori Olympus Co., Ltd.
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal …
Argon Medical Devices, Inc
K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…
Aomori Olympus Co., 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.