Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165; c) 3" RADIAL ARTERIAL LINE KIT, Model Number ART240A; d) 6" FEMORAL ARTERIAL LINE KIT, Model Number ART245A; e) 6" FEMORAL ARTERIAL LINE KIT, Model Number ART245B; f) ARTERIAL LINE BUNDLE, Model Number ART255; g) ARTERIAL LINE BUNDLE, Model Number ART560; h) A LINE TRAY, Model Number ART
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Number TVS4700;
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320; b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A; c) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A; d) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A; e) CENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725; f) INTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915; g) 20CM 7F 3L CVC MAX BARR
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTERIAL LINE TRAY W/O CATHETER, Model Number ART1180; d) ARTERIAL LINE INSERTION KIT, Model Number ART775B; e) ARTERIAL LINE KIT W/O CATHETER, Model Number ART890A; f) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; g) ARTERIAL LINE START KIT W/O CATH, Model Number P42453;
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number DYNJ44322I; e) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348D; f) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348F; g) IR ARM PACK, Model Number DYNJ50712C; h) HYBRID PACK, Model Number DYNJ56907D; i) TUNN
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYNJ58351A
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model Number DYNJ902540N
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND PIV KIT, Model Number DYNDV2397; c) VAD ACCESS, Model Number DYNJ24276C; d) FETAL INTERVENTION, Model Number DYNJ66041; e) FETAL INTERVENTION, Model Number DYNJ66041A; f) FETAL INTERVENTION, Model Number DYNJ66041B
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; b) DBS PACK-LF, Model Number DYNJ0878178J; c) DBS PACK-LF, Model Number DYNJ0878178K; d) NEURO ARTERIOGRAM PACK-LF, Model Number DYNJ0948060F; e) NEURO IR PACK, Model Number DYNJ35066I; f) NEURO IR PACK, Model Number DYNJ35066J; g) IR NEURO PACK, Model Number DYNJ39198L; h) IR NEURO PACK, Model Number DYNJ39198N; i) BASIC PACK, Model N
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY, Model Number DYNJ42902B; e) CENTRAL LINE PACK - COMPANION, Model Number DYNJ47215D; f) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717A; g) PK CUST CENTRAL LINE PACK, Model Number DYNJ60586; h) TUNNEL LINE PACK,
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUIDED IV START KIT, Model Number DYNDV2518; d) VI PACK, Model Number DYNJ64871
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model Number IVS3300; e) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A; f) EPIV PROCEDURE TRAY, Model Number IVS3825; g) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A; h) RADIOLOGY TRAY, Model Number MNS116
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND PACK, Model Number DYNJ56392; f) WMC ULTRASOUND PACK, Model Number DYNJ56392A; g) WMC ULTRASOUND PACK, Model Number DYNJ56392B; h) ULTRASOUND KIT-LF, Model Number DYNJ56507B; i) EVLT PACK, Model Number DYNJ56548B;
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F; e) CHP TRANSPLANT CDS, Model Number CDS983082J; f) CLOSURE CDS, Model Number CDS983704I; g) MIDLINE INSERTION TRAY, Model Number CVI4340; h) PORT INSERTION PACK, Model Number CVI4765; i) MAX
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FACELIFT PACK, Model Number DYNJ55954C; f) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893; g) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A; h) PLASTIC FREE FLAP, Model Number DYNJ67367; i) MAJOR BREAS
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Number TVS4000K
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI680C; c) CVL INSERTION TRAY, Model Number DYNDC1786A; d) UNIVERSAL INSERTION KIT, Model Number ECVC1655; e) CVC INSERTION ACCESSORY KIT, Model Number ECVC7880; f) ULTASOUND GUIDED PIV INSERTION, Model Number IVS3635B
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH1187A; c) PACK,FETOSCOPY, Model Number DYNJ906905B
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PACK, Model Number DYNJ30245; c) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716B; d) CENTRAL LINE INSERTION, Model Number DYNJ63347A; e) TAVR FAIRFAX, Model Number DYNJ63634A; f) PARATHYROID PACK, Model Number DYNJ81389A; g) THYRIOD PACK, Model Number DYNJ83960; h) WMC COCHLEAR IMPLANT ADD ON, Model Number DYNJ90720
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e) BREAST BIOPSY TRAY, Model Number DYNDH1266; f) BREAST BIOPSY TRAY, Model Number DYNDH1345A; g) ULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A; h) BASIC BIOPSY TRAY, Model Number DYNDH1534; i) ULTRASOUND BIOP
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
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