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 · 2026-08-23
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 483 of 819
PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
Vygon U.S.A.
Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Siemens Healthcare Diagnostics, Inc.
Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
Datascope Corporation
BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
Datascope Corporation
Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the pla…
Boston Scientific Corporation
Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using…
TP Orthodontics, Inc.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation d…
Vyaire Medical
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(1…
PerkinElmer Life and Analytical Sciences, Wallac, OY
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Parker Laboratories, Inc.
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Siemens Medical Solutions USA, Inc.
Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material …
Boston Scientific Corporation
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation devices are manual resuscitati…
Vyaire Medical
Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
Zimmer Biomet, Inc.
BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
Datascope Corporation
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are manual resuscitation devices t…
Vyaire Medical
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
Zimmer Biomet, Inc.
ADVIA Centaur¿ Folate (FOL)
Siemens Healthcare Diagnostics, Inc.
IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an ov…
Deerfield Imaging, Inc.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLif…
Vyaire Medical
NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)0085…
Ninepoint Medical Inc.
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fl…
Philips Medical Systems Nederlands
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(…
Southwest Technologies Inc
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics t…
Teleflex Medical Europe Ltd
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
Cook Inc.
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operato…
Radiometer Medical ApS
Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
Beijing Syntech Laser Co., Ltd
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The…
Philips Electronics North America Corporation
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical…
Roche Diagnostics Corporation
SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Perform…
Philips Medical Systems Nederlands
StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52…
Cook Inc.
SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood an…
Cardinal Health 200, LLC
SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical…
Roche Diagnostics Corporation
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the …
Siemens Healthcare Diagnostics, Inc.
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Cook Inc.
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
Cook Inc.
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully automated critica…
Roche Diagnostics Corporation
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Siemens Healthcare Diagnostics, Inc.
Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mu…
IntroMedic Co., Ltd.
Beijing Syntech Laser UL C02 Laser surgical lasers
Beijing Syntech Laser Co., Ltd
SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used …
Beaver-Visitec International Inc.
SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Siemens Healthcare Diagnostics, Inc.
MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be…
Philips Medical Systems Nederlands
Beijing Syntech Laser Diode Laser surgical lasers
Beijing Syntech Laser Co., Ltd
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Siemens Medical Solutions USA, 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.