Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 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 148 of 808
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRA…
American Contract Systems, Inc.
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Aesculap Inc
TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
Howmedica Osteonics Corp.
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
Howmedica Osteonics Corp.
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC…
American Contract Systems, Inc.
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 ye…
Olympus Corporation of the Americas
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
Howmedica Osteonics Corp.
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years)…
Olympus Corporation of the Americas
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
Howmedica Osteonics Corp.
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
MEDLINE INDUSTRIES, LP - Northfield
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
Howmedica Osteonics Corp.
Achieva XR. Model (REF) Numbers 781153, 781253.
Philips North America
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
Howmedica Osteonics Corp.
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface …
Ethicon Endo-Surgery Inc
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
Howmedica Osteonics Corp.
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
Howmedica Osteonics Corp.
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
Howmedica Osteonics Corp.
P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
Howmedica Osteonics Corp.
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Mo…
Olympus Corporation of the Americas
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
MEDLINE INDUSTRIES, LP - Northfield
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
THOR Photomedicine Ltd
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
Aesculap Inc
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit numb…
American Contract Systems, Inc.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
Howmedica Osteonics Corp.
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
Philips North America
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN D…
American Contract Systems, Inc.
DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Howmedica Osteonics Corp.
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Ter…
TERRAGENE S.A.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
Howmedica Osteonics Corp.
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION …
American Contract Systems, Inc.
Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number L…
American Contract Systems, Inc.
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, …
American Contract Systems, Inc.
MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
MEDLINE INDUSTRIES, LP - Northfield
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
Philips North America
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
Howmedica Osteonics Corp.
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
Philips North America
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
Philips North America
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
American Contract Systems, Inc.
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLAST…
American Contract Systems, Inc.
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABO…
American Contract Systems, Inc.
EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 …
Olympus Corporation of the Americas
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
Howmedica Osteonics Corp.
Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVC…
American Contract Systems, Inc.
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
Philips North America
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 2, 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 2, 2026.