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.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS PACK, Model Number: TVS4000K
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY KIT, Model Number: ECVC7880; c. CVL INSERTION TRAY, Model Number: DYNDC1786A; d. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635B; e. USG PIV INSERTION KIT, Model Number: DYNDV2480A;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O; e. BARIATRIC PACK, Model Number: DYNJ24459P; f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242; g. CYSTO PACK, Model Number: DYNJ60667C,
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVER 2018, Model Number: DYNJ905655A;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BREAST BIOPSY TRAY, Model Number: DYNDH1187A;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model Number: DYNJ901745J; e. CENTRAL LINE INSERTION, Model Number: DYNJ63347A; f. CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; g. DBD-CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; h. DBD
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B; b. BASIC BIOPSY TRAY, Model Number: DYNDH1534; c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485; d. BIOPSY PACK-LF, Model Number: DYNJ0747885G; e. BIOPSY RAD CT, Model Number: DYNJ59752A; f. BIOPSY TRAY, Model Number: DYNDH1748, DYNJ34637F, DYNJ34637G, DYNJ43076, DYNJ43076A, DYNJ62690; g. BIOPSY W
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ82989; d. SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267; e. TV IR PICC PACK-LF, Model Number: DYNJ41561D; f. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635A; g. ULTRASOUND GUIDED PI
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; e. AFCH CVC INSERTION, Model Number: DYNJ67534; f. ANGIOGRAM-DECH-LF, Model Number: DYNJ81725; g. ART LINE KIT ICH OR, Model Number: ART900; h. ARTERIAL LINE PACK, Model Numb
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b. ARTERIAL LINE TRAY, Model Number: ART905; c. CATHETERLESS INSERTION KIT, Model Number: CVI4510; d. OR CATHETER INSERTION SETUP PACK, Model Number: ECVC7165A; e. VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number: STCVC01145B; f. VANTEX TRIPLE LUMEN BUNDLE, Model Number: STCVC2000;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYNJ53438A, DYNJ53610C, DYNJ53995G, DYNJ56791A, DYNJ56791B, DYNJ57490A, DYNJ58608, DYNJ58681A, DYNJ58681B, DYNJ58710, DYNJ61325A, DYNJ61325B, DYNJ61528, DYNJ62399A, DYNJ65160, DYNJ66356, DYNJ66356A, DYNJ66356B, DYNJ66356C,
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C; d. OPEN HEART PACK A B, Model Number: DYNJ53984G; e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G; f. OPEN HEART PACK-LF,
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G; d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C; e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567; f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N; g. ENDOVASCULAR,
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d. ABLATION PACK, Model Number: DYNJ61957A; e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F; f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M; g. AFIB PACK, Model Number: DY
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595; e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V; f. CVC 16CM BUNDLE, Model Number: ECVC2225; g. CVC 3L 7F 20CM VANT
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A; d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095; e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A; f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A; g. 16CM TRIPLE
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N; d. ANGIO DRAPE PACK, Model Number: DYNJ17624B, DYNJ44320F; e. ANGIO DRAPE SPEC PROC PACK, Model Number: DYNJ47951A; f. ANGIO LEFT HEART PACK, Model Number: DYNJ40632C; g.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJR
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA1864; d. BLOCK KIT, Model Number: DYNJRA1893; e. DR LEWIS US TRAY, Model Number: DYNJRA1998; f. ECHOGENIC SINGLE SHOT TRAY, Model Number: DYNJRA1978, DYNJRA1978A, SAMPA0109; g. FEMORAL BLOCK TRAY, Mod
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number: ART995; d. ARTERIAL LINE INSERTION KIT, Model Number: ART775B; e. ARTERIAL LINE KIT W/O CATHETER, Model Number: ART890A; f. ARTERIAL LINE START KIT, Model Number: ART1160; g. ARTERIAL LINE START KIT W/O
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANESTHESIA CVL KIT-LF, Model Number: DYNJ52283C; b. ANESTHESIA OH TOTE, Model Number: DYNJ61476;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Number DYNJE5920; d. COVER, PROBE, W/GEL AND BANDS, 6X96 - Model Number DYNJE5930; e. COVER, PROBE, W/GEL AND BANDS, 5X48 - Model Number DYNJE5940; f. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJEX5900
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceJohnson & Johnson Surgical Vision, Inc.Class IITECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
- 2023-08-09FDA-DeviceJohnson & Johnson Surgical Vision, Inc.Class IITECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
- 2023-08-09FDA-DeviceMaterialise N.V.Class IIProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
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