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 359 of 819
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Catheter is no…
Abbott Vascular
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Siemens Healthcare Diagnostics, Inc.
Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotom…
Nobel Biocare Usa Llc
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative me…
Abbott Point Of Care Inc.
Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
Arrow International Inc
Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteoto…
Nobel Biocare Usa Llc
TLC-2000 Therapeutic Medical Laser System
Theralase Inc.
Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation a…
Covidien LLC
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and…
Covidien LLC
Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligatio…
Covidien LLC
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
Arrow International Inc
Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation a…
Covidien LLC
Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or li…
Covidien LLC
Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomi…
Nobel Biocare Usa Llc
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. …
Cardinal Health 200, LLC
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at lea…
Philips Respironics, Inc.
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated …
Abbott Vascular
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Advanced Bionics, LLC
Arrow EPIDURAL CATHETERIZATION KIT YC-02220
Arrow International Inc
Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and…
Covidien LLC
Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damage…
Nobel Biocare Usa Llc
Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation an…
Covidien LLC
Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
Arrow International Inc
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Philips North America LLC
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Smith & Nephew, Inc.
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. …
Philips Respironics, Inc.
Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation a…
Covidien LLC
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enabl…
Siemens Medical Solutions USA, Inc
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation…
Covidien LLC
i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantita…
Abbott Point Of Care Inc.
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated…
Abbott Vascular
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
Arrow International Inc
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Philips Medical Systems Gmbh, DMC
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
Ethicon, Inc.
Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or lig…
Covidien LLC
Arrow EPIDURAL CATHETERIZATION KIT CK-02220
Arrow International Inc
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated…
Abbott Vascular
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Philips North America LLC
(1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPN…
Arrow International Inc
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. …
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 …
Philips Respironics, Inc.
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.…
Philips Respironics, Inc.
Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation a…
Covidien LLC
Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation …
Covidien LLC
SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Ormco/Sybronendo
Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 …
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 k…
Philips Respironics, Inc.
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated…
Abbott Vascular
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
Siemens Healthcare Diagnostics, Inc.
Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation …
Covidien LLC
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.