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 · 2026-09-23

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 2026-09-23. 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 2026-09-23.
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 85 of 822

FDA Devices Moderate Apr 2, 2025

Baxter Stationary column TruSystem 7500 U, Product Code 1730731

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pack Number DYNJ63532; 7) BASIC PACK, Pack Number DYNJ81702; 8) BASIC PACK, Pack Number DYNJ36595D; 9) BASIC PACK, Pack Number DYNJ69250A; 10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C; 11) BGMC ADULT HERNIA P

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TRAY, Pack Number DYNDH1937; 7) ARTHROSCOPY KNEE PACK-LF, Pack Number DYNJ0809731F; 8) ARTHROSCOPY PACK, Pack Number DYNJ66665; 9) ARTHROSCOPY PACK, Pack Number DYNJ38716C; 10) ARTHROSCOPY PACK, Pack Number DYNJ33639J;

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Baxter Operating table column TS7500 MOBIUS, Product Code 1704695

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ42873; 7) ANGIOGRAPHY PACK, Pack Number DYNJ57498; 8) ANGIOGRAPHY PACK, Pack Number DYNJ52167A; 9) ANGIOGRAPHY PACK, Pack Number DYNJV0173I; 10) ANGIOGRAPHY TRAY-LF, Pack Num

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PACK-LF, Pack Number DYNJ0046667A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF, Pack Number DYNJ55345D; 7) C-SECTION PACK, Pack Number DYNJ04521J; 8) C-SECTION PACK, Pack Number DYNJ32632F; 9) C-SECTION PACK, Pack Number DYNJ65961B; 10) SMJ C-SECTION PACK-LF, Pack Number DYNJ38582J

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No

American Contract Systems, Inc.

FDA Devices Moderate Apr 2, 2025

Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP A PACK, Pack Number DYNJ40647G; 7) IPMC BREAST PACK-LF, Pack Number DYNJ0665560D; 8) OCULAR PLASTICS PACK, Pack Number DYNJ40356A; 9) OCULOPLASTY PACK-LF, Pack Number DYNJ0252232U; 10) PACK MASTECTOMY COMBO CHRG

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

Zimmer, Inc.

FDA Devices Critical Apr 2, 2025

CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.

Calyxo, Inc.

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ61266A; 6) ANGIOGRAPHY PACK-LF, Pack Number DYNJ35916N; 7) ARTERIOGRAM PACK, Pack Number DYNJ34442F; 8) CARDIAC CATH FEMORAL PACK, Pack Number DYNJ53588I; 9) CARDIAC CATH PACK, Pack Number DYNJ31733C; 10) CARDI

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Baxter Floor mounting column TruSystem 7500, Product Code 1717021

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Baxter Floor mounting column TS 7500 U, Product Code 1730732

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Baxter Mobile column TruSystem 7500, Product Code 1717023

Baxter Healthcare Corporation

FDA Devices Moderate Mar 26, 2025

MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology Length 7 (2.0 m), XS04620COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), XS04624COV

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVIIH; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft High Humidity, MVIIHH; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 4m/13ft Extended Duration, MVIIHL; Microstream Advance Neonatal-Infant Intubated CO2 Filter

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICROSTREAM FilterLine Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter, 007768; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 010579; MICROSTREAM FilterLine H Set Adult-

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

LABOR & DELIVERY PACK, Model Nos LLLD19H

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

C-SECTION PACK, Model Nos LLCS44F LLCS44F-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

Remel, Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

DIAGNOSTIC NEURO IR TRAY , Model No WENE21

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

DELIVERY PACK , Model No SGDV22D-01 SGDV22E

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI100U; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVAIH; Micr

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

CYSTO , Model No SACY80R

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02

American Contract Systems 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

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.