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 95 of 808
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN…
Smith & Nephew Inc
KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number…
King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number…
King Systems Corp. dba Ambu, Inc.
MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray …
Integra LifeSciences Corp.
SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, in…
Integra LifeSciences Corp.
SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, inclu…
Integra LifeSciences Corp.
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 20828…
DATEX--OHMEDA, INC.
SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in protection of tissue, including…
Integra LifeSciences Corp.
Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicab…
West Pharmaceutical Services AZ, Inc.
SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in protection of tissue, includi…
Integra LifeSciences Corp.
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTS…
King Systems Corp. dba Ambu, Inc.
Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system…
Olympus Corporation of the Americas
KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
King Systems Corp. dba Ambu, Inc.
Harbor Freight Tools Recalls Bauer 4-Gallon Battery-Powered Backpack Sprayers Due to Fire Hazard
Humane Recalls Charge Case Accessory for Ai Pin Due to Lithium Battery Fire Hazard
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B;…
MEDLINE INDUSTRIES, LP - Northfield
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and a…
Datex-Ohmeda, Inc.
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
Baxter Healthcare Corporation
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK T…
MEDLINE INDUSTRIES, LP - Northfield
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR …
MEDLINE INDUSTRIES, LP - Northfield
SynchroMed II Infusion Pump. Product Number: 8637-20
Medtronic Neuromodulation
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
medex Arterial Kit 1/EA, Product Code REF MX7827
Smiths Medical ASD, Inc.
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Smiths Medical ASD, Inc.
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Smiths Medical ASD, Inc.
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Smiths Medical ASD Inc.
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC24…
MEDLINE INDUSTRIES, LP - Northfield
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used …
Datex-Ohmeda, Inc.
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
Baxter Healthcare Corporation
Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Smiths Medical ASD Inc.
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent…
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentar…
Olympus Corporation of the Americas
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
Smiths Medical ASD, Inc.
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM,…
Smiths Medical ASD Inc.
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patient…
Datex-Ohmeda, Inc.
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Smiths Medical ASD Inc.
Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used on…
Datex-Ohmeda, Inc.
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Ad-Tech Medical Instrument Corporation
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Olympus Corporation of the Americas
Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only b…
Datex-Ohmeda, Inc.
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Smiths Medical ASD Inc.
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Smiths Medical ASD, Inc.
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
Baxter Healthcare Corporation
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
Smiths Medical ASD, Inc.
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007…
Baxter Healthcare Corporation
Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; …
MEDLINE INDUSTRIES, LP - Northfield
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.