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 9 of 808
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (B…
Angiodynamics, Inc.
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; Pro…
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 i…
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)27063…
ARROW INTERNATIONAL, LLC
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN P…
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 (Bo…
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),…
Angiodynamics, Inc.
nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 2…
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.: H7871071404…
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: D…
Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOP…
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 Prod…
THERAKOS DEVELOPMENT LIMITED
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination wi…
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 CERVI…
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…
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.…
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-1-1…
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…
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 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.