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 112 of 808
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) …
Smiths Medical ASD Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001865;
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001878;
Beaver Visitec International, Inc.
Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissec…
Stryker Corporation
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020;
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000288;
Beaver Visitec International, Inc.
Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A
MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number DYKB1011B; 3) BABY KIT, Pa…
MEDLINE INDUSTRIES, LP - Northfield
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000287;
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000404;
Beaver Visitec International, Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC …
Smiths Medical ASD Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000508;
Beaver Visitec International, Inc.
Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY…
MEDLINE INDUSTRIES, LP - Northfield
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001315;
Beaver Visitec International, Inc.
Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036B
MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H
MEDLINE INDUSTRIES, LP - Northfield
Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT6135BH; 3) CIRCUMCISION TRA…
MEDLINE INDUSTRIES, LP - Northfield
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001634;
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584630;
Beaver Visitec International, Inc.
Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) RETINAL INJECTION KIT, Pack Nu…
MEDLINE INDUSTRIES, LP - Northfield
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/…
Smiths Medical ASD Inc.
Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number…
MEDLINE INDUSTRIES, LP - Northfield
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001699;
Beaver Visitec International, Inc.
Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A
MEDLINE INDUSTRIES, LP - Northfield
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001478;
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000803;
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001014;
Beaver Visitec International, Inc.
Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP…
MEDLINE INDUSTRIES, LP - Northfield
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/L…
Smiths Medical ASD Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001467;
Beaver Visitec International, Inc.
Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A
MEDLINE INDUSTRIES, LP - Northfield
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000828;
Beaver Visitec International, Inc.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001631;
Beaver Visitec International, Inc.
Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic kn…
Alcon Research LLC
Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
Alcon Research LLC
Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Intrinsic Therapeutics, Inc.
LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
MEDLINE INDUSTRIES, LP - Northfield
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Covidien
Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Op…
Alcon Research LLC
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Stryker Sustainability Solutions
Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Description: Op…
Alcon Research LLC
Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Op…
Alcon Research LLC
Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmi…
Alcon Research LLC
Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Descrip…
Alcon Research LLC
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT,…
MEDLINE INDUSTRIES, LP - Northfield
Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic kn…
Alcon Research LLC
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
BioFire Diagnostics, LLC
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appro…
Beckman Coulter Mishima K.K.
Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Microtek Medical Inc.
Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Op…
Alcon Research 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 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.