PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
41,070
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
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

41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-26

Do more recalls mean more Class I danger?

Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.

Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-26. 2×2 strategic matrix plotting 7 entities by Total recalls (count) (X) and Class I share of classified (%) (Y), with a crosshair dividing the plot into four quadrants. Large · Class I–heavySmaller · Class I–heavyLarge · fewer Class ISmaller · fewer Class I 010,00020,00030,00040,00050,000 0%20%40%60%80% Total recalls (count) Class I share of classified (%) Category volume vs Class I rate Signature insight Medical DevicesFoodDrugs & MedicationsChildren & Baby ProductsDietary SupplementsMeat & PoultryCosmetics & Personal Care
Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-26.
Read the chart, every category as text

Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.

CategoryRecallsVol %ileClassifiedClass IClass I %Rate %ile
Medical Devices41,07010040,7633,6539%14
Food25,5138625,22211,67646.3%86
Drugs & Medications14,4737114,4171,50810.5%29
Children & Baby Products4,017572,48335214.2%43
Dietary Supplements2,018431,99346623.4%71
Meat & Poultry1,672291,6721,14568.5%100
Cosmetics & Personal Care1,388141,28920315.7%57

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

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 126 of 822

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001865;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001878;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-107-030D

Stryker Corporation

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000288;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number DYKB1011B; 3) BABY KIT, Pack Number DYKP1021; 4) BABY KIT MED CENTER, Pack Number DYKM2149; 5) BABY KIT MED CENTER, Pack Number DYKM2149A; 6) GIRAFFE BED KIT, Pack Number DYKL1839; 7) GIRAFFE BED KIT, Pack Number DYKL1839H; 8) NEWBORN SUPPLIES, Pack Number ACC010791; 9) NEWBORN SUPPLIES + POSTPARTUM, Pack Number ACC010597C; 10) NEWBORN KIT, Pack Number DYKL18

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000287;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000404;

Beaver Visitec International, Inc.

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P05

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000508;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE EPI TRAY, Pack Number DYNDA2965; 7) MAMMOGRAPHY TRAY, Pack Number DYNDH1094; 8) FTMC PAIN TRAY, Pack Number DYNDH1239D; 9) LUMBAR PUNCTURE - CHLORAPREP, Pack Number DYNDH1351B ; 10) PAIN MANAGEMENT PACK, Pack Number D

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001315;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036B

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

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

FDA Devices Moderate Sep 4, 2024

Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT6135BH; 3) CIRCUMCISION TRAY , Pack Number CIT2465; 4) CIRCUMCISION TRAY , Pack Number CIT4920; 5) CIRCUMCISION TRAY , Pack Number CIT7455; 6) CIRCUMCISION TRAY , Pack Number DYNDA3045; 7) CIRCUMCISION TRAY , Pack Number DYNDL1889; 8) CIRCUMCISION TRAY , Pack Number CIT7455H ; 9) CIRCUMCISION TRAY W/1.3 CLAMP , Pack Number CIT6075; 10) CIRCUMCISON TRAY, Pack Num

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001634;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584630;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) RETINAL INJECTION KIT, Pack Number MNS12465

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001699;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001478;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000803;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001014;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX TRAY, Pack Number DYNDH1050A; 7) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 8) CATHETER ON/OFF KIT, Pack Number DT5490B; 9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 10) CHEST TUBE INSERTION TRAY, Pack Numbe

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Sep 4, 2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001467;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000828;

Beaver Visitec International, Inc.

FDA Devices Moderate Sep 4, 2024

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001631;

Beaver Visitec International, Inc.

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A

Intrinsic Therapeutics, Inc.

FDA Devices Moderate Aug 28, 2024

LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Aug 28, 2024

McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only

Covidien

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A

Stryker Sustainability Solutions

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

BioFire Diagnostics, LLC

FDA Devices Moderate Aug 28, 2024

DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

Beckman Coulter Mishima K.K.

FDA Devices Moderate Aug 28, 2024

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.

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A

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

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.