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 363 of 819
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Flowonix Medical Inc
Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA902…
Pacific Medical Group Inc.
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID
Arrow International Inc
Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1…
Taewoong Medical Co., Ltd.
Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45…
Microvention, Inc.
HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
TELEFLEX MEDICAL INC
EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU
Arrow International Inc
Respironics V680 Ventilator, Service # 850011, (OUS Only)
Respironics California, LLC
HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
TELEFLEX MEDICAL INC
Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-78020…
Microvention, Inc.
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 …
Philips North America, LLC
FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220
Arrow International Inc
Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is Mic…
Microvention, Inc.
FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME
Arrow International Inc
Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G498…
Cook Inc.
AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
Cardinal Health
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Roche Diabetes Care, Inc.
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
Cardinal Health
Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O …
Centurion Medical Products Corporation
PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
Cook Inc.
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Clinical Diagnostic Solutions, Inc.
Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
Cook Inc.
da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to p…
Intuitive Surgical, Inc.
Centurion- ENT SNUF3 SNUFFER KIT Y
Centurion Medical Products Corporation
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
Cardinal Health
AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
Cardinal Health
Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY
Centurion Medical Products Corporation
Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
Centurion Medical Products Corporation
Vaginal Verification Panel Ref 8208 Lot 8208-11
Microbiologics Inc
da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to…
Intuitive Surgical, Inc.
Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
Cook Inc.
Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495…
Centurion Medical Products Corporation
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Cook Inc.
Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY
Centurion Medical Products Corporation
da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimall…
Intuitive Surgical, Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Pacific Medical Group Inc.
Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
Roche Diabetes Care, Inc.
Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
Implant Direct Sybron Manufacturing LLC
Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY CHT1760 CHEST…
Centurion Medical Products Corporation
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
Cardinal Health
Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
Centurion Medical Products Corporation
Y-Type Blood Set, Catalog Number 490425
B. Braun Medical, Inc.
Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION
Centurion Medical Products Corporation
AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
Cardinal Health
Y-Type Blood Set, Catalog Number 490293
B. Braun Medical, Inc.
Centurion- OR2020 BASIN SET
Centurion Medical Products Corporation
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Cardinal Health
Y-Type Blood Set, Catalog Number 490530
B. Braun Medical, Inc.
Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
Cook Inc.
Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
Cook 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.