Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- 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 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 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 71 of 810
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ01…
MEDLINE INDUSTRIES, LP - Northfield
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (…
Checkpoint Surgical Inc
Baxter Stationary column TruSystem 7500 U, Product Code 1730731
Baxter Healthcare Corporation
Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PAC…
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF…
MEDLINE INDUSTRIES, LP - Northfield
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
Baxter Healthcare Corporation
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…
MEDLINE INDUSTRIES, LP - Northfield
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
MEDLINE INDUSTRIES, LP - Northfield
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
Baxter Healthcare Corporation
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number…
MEDLINE INDUSTRIES, LP - Northfield
Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, …
Baxter Healthcare Corporation
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 …
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Num…
MEDLINE INDUSTRIES, LP - Northfield
Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Conven…
American Contract Systems, Inc.
Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
Baxter Healthcare Corporation
Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREA…
MEDLINE INDUSTRIES, LP - Northfield
Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
Baxter Healthcare Corporation
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Zimmer, Inc.
CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Calyxo, Inc.
Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPH…
MEDLINE INDUSTRIES, LP - Northfield
Baxter Floor mounting column TruSystem 7500, Product Code 1717021
Baxter Healthcare Corporation
Baxter Floor mounting column TS 7500 U, Product Code 1730732
Baxter Healthcare Corporation
Baxter Mobile column TruSystem 7500, Product Code 1717023
Baxter Healthcare Corporation
APOTHEKE Recalls Pumpkin Ginger 3-Wick Scented Candles Due to Fire, Burn and Laceration Hazards; Sold Exclusively at Crate & Barrel
APOTHEKE, of Brooklyn, New York
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
American Contract Systems Inc
Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 101294…
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Mic…
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 -…
Oridion Medical 1987 Ltd.
LABOR & DELIVERY PACK, Model Nos LLLD19H
American Contract Systems Inc
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstr…
Oridion Medical 1987 Ltd.
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
American Contract Systems Inc
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 DR…
MEDLINE INDUSTRIES, LP - Northfield
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Smiths Medical ASD, Inc.
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
American Contract Systems Inc
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
American Contract Systems Inc
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 YV40…
Remel, Inc
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-…
Smiths Medical ASD, Inc.
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
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information syst…
Merge Healthcare, Inc.
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
American Contract Systems Inc
DELIVERY PACK , Model No SGDV22D-01 SGDV22E
American Contract Systems Inc
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 …
Oridion Medical 1987 Ltd.
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 integr…
Merge Healthcare, Inc.
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
American Contract Systems Inc
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 Introd…
Smiths Medical ASD, Inc.
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
American Contract Systems Inc
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
American Contract Systems Inc
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
American Contract Systems Inc
CYSTO , Model No SACY80R
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
- 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 Jun 3, 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 Jun 3, 2026.