Product category · Updated Aug 19, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
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 · 2026-09-20
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.
Read the chart, every category as text
Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.
| Category | Recalls | Vol %ile | Classified | Class I | Class I % | Rate %ile |
|---|---|---|---|---|---|---|
| Medical Devices | 41,070 | 100 | 40,763 | 3,653 | 9% | 14 |
| Food | 25,513 | 86 | 25,222 | 11,676 | 46.3% | 86 |
| Drugs & Medications | 14,473 | 71 | 14,417 | 1,508 | 10.5% | 29 |
| Children & Baby Products | 4,017 | 57 | 2,483 | 352 | 14.2% | 43 |
| Dietary Supplements | 2,018 | 43 | 1,993 | 466 | 23.4% | 71 |
| Meat & Poultry | 1,672 | 29 | 1,672 | 1,145 | 68.5% | 100 |
| Cosmetics & Personal Care | 1,388 | 14 | 1,289 | 203 | 15.7% | 57 |
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 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 23 of 822
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
Angiodynamics, Inc.
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
ARROW INTERNATIONAL, LLC
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Olympus Corporation of the Americas
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Windstone Medical Packaging, Inc.
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection agains
ARROW INTERNATIONAL, LLC
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES DYNJ60329A CENTRAL VENOUS ACCESS PACK-LF CVI5070 FISTULAGRAM PACK DYNJ66259 INVASIVE LINE INSERTION DYNJ44123C NON VASCULAR PACK DYNJ68037B, DYNJ68037C PICC ABSCESS PACK-LF DYNJ0774005G PICC LINEPACK (PCLUI)642-LF DYNJ47717B PICC PHC DYNJ37484C
Medline Industries, LP
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Foundation Medicine, Inc.
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
Medline Industries, LP
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Remel Europe Ltd.
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
Angiodynamics, Inc.
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
Angiodynamics, Inc.
nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc
XTANT Medical Holdings, Inc
Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;
Angiodynamics, Inc.
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
Medline Industries, LP
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Diversatek Healthcare
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817
Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599
Medline Industries, LP
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Olympus Corporation of the Americas
React Health PHOENIX 5L Oxygen Concentrator
3B Medical, Inc.
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Insulet Corporation
Yeastone Broth, 11ML, 10/BOX YY3462
Remel, Inc
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Gentuity, LLC
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Integra LifeSciences Corp. (NeuroSciences)
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Wilson-Cook Medical Inc.
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patie
THERAKOS DEVELOPMENT LIMITED
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Beta Bionics, Inc.
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿
Clariance-SAS
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Integra LifeSciences Corp. (NeuroSciences)
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
B Braun Medical Inc
Philips Spectral CT on Rails. Model Number: 728334.
PHILIPS MEDICAL SYSTEMS
ARTIS Pheno VE30A and VE40A, Model 10849000
Siemens Medical Solutions USA, Inc
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Medline Industries, LP
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
B Braun Medical Inc
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
B Braun Medical Inc
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Integra LifeSciences Corp. (NeuroSciences)
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
Linkbio Corp.
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
B Braun Medical Inc
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Integra LifeSciences Corp. (NeuroSciences)
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Integra LifeSciences Corp. (NeuroSciences)
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
B Braun Medical Inc
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
B Braun Medical Inc
Mini Round Toddler Trampolines Recalled Due to Strangulation Hazard; Risk of Serious Injury or Death; Manufactured by SEGMART
Shenzhen Segmart Technology Electronics Co., Ltd., of China
Sanlebi Pet Vet Playsets Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by Letokids
Guangzhou Letao Keji Youxiangongsi, doing business as Letokids, of China
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
XTANT Medical Holdings, Inc
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A.
Medline Industries, LP
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
Cook Incorporated
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.
Medline Industries, LP
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8.
Medline Industries, LP
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 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.