Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Alcon Research Llc
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalm...
Medical Devices·4,930 affected·Apr 22, 2024
High RiskFDA
Alcon Research Llc
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Medical Devices·29,190 affected·Apr 22, 2024
High RiskFDA
Alcon Research Llc
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalm...
Medical Devices·19,867 affected·Apr 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
Medical Devices·25,214,334 affected·Apr 22, 2024
High RiskFDA
Philips North America Llc
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Medical Devices·358 affected·Apr 19, 2024
High RiskFDA
Bd Switzerland Sarl
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery o...
Medical Devices·11 affected·Apr 18, 2024
CriticalFDA
Optumhealth Care Solutions Llc
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Medical Devices·208 affected·Apr 18, 2024
High RiskFDA
Exactech, Inc.
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Medical Devices·0 affected·Apr 18, 2024
High RiskFDA
Exactech, Inc.
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 2...
Medical Devices·0 affected·Apr 18, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Blood Pump Rotor, Model Number: F40015481 Rev A
Medical Devices·45,880 affected·Apr 17, 2024
High RiskFDA
Nrt X-ray A/s
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Medical Devices·35 affected·Apr 17, 2024
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Medical Devices·1,822 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices·12,292 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices·334 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Medical Devices·931 affected·Apr 17, 2024
High RiskFDA
Cardinal Health 200, Llc
CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
Medical Devices·2,000 affected·Apr 17, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Medical Devices·11,371 affected·Apr 17, 2024
High RiskFDA
Tornier S.a.s.
Stryker Blueprint Software, Catalog #BPUE001.
Medical Devices·0 affected·Apr 16, 2024
CriticalFDA
Carefusion 303, Inc.
BD Pyxis(TM) Anesthesia Station 4000, REF: 338
Medical Devices·11,875 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·68 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·1,635 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·40 affected·Apr 15, 2024
CriticalFDA
Carefusion 303, Inc.
BD Pyxis" Anesthesia Station ES, REF: 327
Medical Devices·71,569 affected·Apr 15, 2024
CriticalFDA
Carefusion 303, Inc.
BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
Medical Devices·91,933 affected·Apr 15, 2024
High RiskFDA
Stryker Orthopaedics
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4...
Medical Devices·20 affected·Apr 15, 2024
High RiskFDA
Medartis Inc.
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Medical Devices·110 affected·Apr 12, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extr...
Medical Devices·18 affected·Apr 11, 2024
High RiskFDA
Securitas Healthcare Llc
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the...
Medical Devices·661 affected·Apr 11, 2024
High RiskFDA
Leica Biosystems Nussloch Gmbh
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Medical Devices·141 affected·Apr 10, 2024
High RiskFDA
Sophysa S.a.
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pres...
Medical Devices·3,175 affected·Apr 9, 2024
High RiskFDA
Sophysa S.a.
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pres...
Medical Devices·3,487 affected·Apr 9, 2024
High RiskFDA
Ge Medical Systems Information Technologies Inc
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/...
Medical Devices·23,180 affected·Apr 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pac...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
see RES for description
Medical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Numb...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; ...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALY...
Medical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P...
Medical Devices·0 affected·Apr 8, 2024
CriticalFDA
Medline Industries, Lp - Northfield
Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA...
Medical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT B...
Medical Devices·1,679,067 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RET...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RAD...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ;...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049...
Medical Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
Medical Devices·0 affected·Apr 8, 2024