Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Maquet Cardiovascular, Llc
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Medical Devices·33,823 affected·Oct 16, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G ...
Medical Devices·3,744 affected·Oct 16, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
Medical Devices·5,975 affected·Oct 16, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A
Medical Devices·3,396 affected·Oct 16, 2024
High RiskFDA
Maquet Cardiovascular, Llc
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Medical Devices·10,778 affected·Oct 16, 2024
High RiskFDA
Smith & Nephew, Inc.
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar ...
Medical Devices·21 affected·Oct 15, 2024
CriticalFDA
Draeger Medical, Inc.
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for us...
Medical Devices·25 affected·Oct 15, 2024
CriticalFDA
Draeger Medical, Inc.
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Medical Devices·455 affected·Oct 15, 2024
CriticalFDA
Draeger Medical, Inc.
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Medical Devices·1,492 affected·Oct 15, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Medical Devices·48 affected·Oct 15, 2024
High RiskFDA
Baxter Healthcare Corporation
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Medical Devices·1,003 affected·Oct 11, 2024
CriticalFDA
Hologic, Inc
BioZorb Marker. Radiographic soft tissue marker.
Medical Devices·12,710 affected·Oct 10, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CO...
Medical Devices·1,035 affected·Oct 10, 2024
High RiskFDA
Shimadzu Corp. Analytical & Measuring Instruments Div.
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Medical Devices·48 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Medical Devices·44 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BAS...
Medical Devices·182 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, R...
Medical Devices·1,271 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
Medical Devices·30 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, RE...
Medical Devices·58,765 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
Medical Devices·36 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK...
Medical Devices·12,847 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intr...
Medical Devices·2,921 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intr...
Medical Devices·2,229 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intra...
Medical Devices·864 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
Medical Devices·486 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for in...
Medical Devices·288 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intra...
Medical Devices·768 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN ...
Medical Devices·13,057 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCI...
Medical Devices·828 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Medical Devices·88 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/...
Medical Devices·478 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for in...
Medical Devices·1,920 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intra...
Medical Devices·1,013 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF...
Medical Devices·3,452 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR ...
Medical Devices·0 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intra...
Medical Devices·1,056 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
Medical Devices·102,561 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL P...
Medical Devices·944 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
Medical Devices·66 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-...
Medical Devices·1,952 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) P...
Medical Devices·336 affected·Oct 9, 2024
High RiskFDA
The Metrix Company
CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for in...
Medical Devices·1,440 affected·Oct 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYN...
Medical Devices·1,921 affected·Oct 9, 2024
High RiskFDA
Cook Incorporated
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Medical Devices·5,953 affected·Oct 8, 2024
High RiskFDA
Hobbs Medical, Inc.
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
Medical Devices·10 affected·Oct 4, 2024
High RiskFDA
Hobbs Medical, Inc.
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Medical Devices·198 affected·Oct 4, 2024
High RiskFDA
Hobbs Medical, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
Medical Devices·15 affected·Oct 4, 2024
High RiskFDA
Hobbs Medical, Inc.
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Medical Devices·12 affected·Oct 4, 2024