🔍 RecallPedia

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810; d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915; e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770; f. IV SECUREMENT KIT, Model Number: DYNDV2407A; g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005; h. MIDLINE INSERTION TRAY, Model Number: CVI4340; i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011; j. MIDLINE KIT 4F SL MB, Model Number: MID0001; k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003; l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A; m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB; n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765; o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B; p. NICU PICC TRAY, Model Number: CVI3740A; q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990; r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B; s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865; t. PICC BUNDLE 5FR DL, Model Number: PICC0013; u. PICC INSERTION BUNDLE, Model Number: DT14560; v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820; w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012; x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; y. PIV BSI KIT, Model Number: BSIPIV1010; z. PIV KIT, Model Number: BSIPIV1004; aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A; bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700; cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A; dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350; ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547; ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006; gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385; hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075; ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011; jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B; kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005; ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715; mm. ULTRASOUND IV START KIT, Model Number: IV8790; nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C; oo. ULTRASOUND PIV KIT, Model Number: IVS3970; pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910; qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125; rr. USG IV START KIT, Model Number: DYNDV2435; ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567; tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01; uu. USGPIV KIT, Model Number: DYNDV2578; vv. USPIV KIT, Model Number: IVS3910; ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880; xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A; yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A; zz. VI PACK, Model Number: DYNJ64871

Class I - Dangerous
🏥 Medical Devices Recalled: May 15, 2023 MEDLINE INDUSTRIES, LP - Northfield Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNDA2482, UPC Number: 10193489198188. b. Model Number: ART920, UPC Number: 10653160327899. c. Model Number: DT19810, UPC Number: 10653160285656. d. Model Number: CVI4915, UPC Number: 10653160355489. e. Model Number: IVS3770, UPC Number: 10653160328230. f. Model Number: DYNDV2407A, UPC Number: 019348981701. g. Model Number: MID0005, UPC Number: 10653160349181. h. Model Number: CVI4340, UPC Number: 10653160309475. i. Model Number: MIDST04011, UPC Number: 10653160350699. j. Model Number: MID0001, UPC Number: 10193489381627. k. Model Number: DYNJ80141MB, UPC Number: 10889942733415; Model Number: MID0003, UPC Number: 10653160349334. l. Model Number: PICC0009A, UPC Number: 10193489760231. m. Model Number: DYNJ80152MB, UPC Number: 10889942733422. n. Model Number: DYNDA2509A, UPC Number: 10193489196986; Model Number: MNS8765, UPC Number: 10653160270515. o. Model Number: DYNDC2120B, UPC Number: 10193489198270. p. Model Number: CVI3740A, UPC Number: 10653160324416. q. Model Number: IVS3990, UPC Number: 10653160345282. r. Model Number: CVI4450B, UPC Number: 10653160358428. s. Model Number: DYNDV2285, UPC Number: 10193489194548; Model Number: MNS9865, UPC Number: 10653160294436. t. Model Number: PICC0013, UPC Number: 10653160351818. u. Model Number: DT14560, UPC Number: 10653160236887. v. Model Number: CVI3805, UPC Number: 10653160265085; Model Number: CVI3820, UPC Number: 10653160273509. w. Model Number: DYNJ70141MB, UPC Number: 10889942722808; Model Number: PICC0010, UPC Number: 10653160349112; Model Number: PICC0011, UPC Number: 10653160350842; Model Number: PICC0012, UPC Number: 10653160350491. x. Model Number: DYNJ70152MB, UPC Number: 10889942722822. y. Model Number: BSIPIV1010, UPC Number: 10653160356523. z. Model Number: BSIPIV1004, UPC Number: 10193489198843. aa. Model Number: DYNJ68937A, UPC Number: 10193489111545. bb. Model Number: CVI3700, UPC Number: 10653160259763. cc. Model Number: IVS3705, UPC Number: 10653160325819; Model Number: IVS3705A, UPC Number: 10653160342885; Model Number: IVS3905A, UPC Number: 10653160344391. dd. Model Number: IVS3350, UPC Number: 10653160313045. ee. Model Number: DYNDV2465, UPC Number: 10193489110166; Model Number: DYNDV2518, UPC Number: 019532708907; Model Number: DYNDV2547, UPC Number: 10653160354246. ff. Model Number: BSIPIV1006, UPC Number: 10653160356936. gg. Model Number: DYNDV2385, UPC Number: 10193489195217. hh. Model Number: IVS4075, UPC Number: 10653160350545. ii. Model Number: BSIPIV1011, UPC Number: 10653160353317. jj. Model Number: IVS3485A, UPC Number: 10653160328612; Model Number: IVS3840, UPC Number: 10653160341994; Model Number: IVS3840A, UPC Number: 10653160344612; Model Number: IVS3940, UPC Number: 10653160342304; Model Number: IVS3940A, UPC Number: 10653160345664; Model Number: IVS3940B, UPC Number: 10653160355335. kk. Model Number: BSIPIV1005, UPC Number: 10193489198867; Model Number: DYNDA2669, UPC Number: 10193489191912; Model Number: IVS3300, UPC Number: 10653160307662; Model Number: IVS3420A, UPC Number: 10653160342205; Model Number: IVS3420B, UPC Number: 10653160359067; Model Number: IVS3495, UPC Number: 10653160316596; Model Number: IVS3505, UPC Number: 10653160323761; Model Number: IVS3655B, UPC Number: 10653160358107; Model Number: IVS3900, UPC Number: 10653160344810; Model Number: IVS3900A, UPC Number: 10653160347774; Model Number: IVS4005, UPC Number: 10653160346142. ll. Model Number: IVS3715, UPC Number: 10653160326298. mm. Model Number: IV8790, UPC Number: 019348936055. nn. Model Number: IV8635A, UPC Number: 10653160324010; Model Number: IV8635B, UPC Number: 10653160327622; Model Number: IV8635C, UPC Number: 10653160344858. oo. Model Number: IVS3970, UPC Number: 10653160343431. pp. Model Number: CVI3910, UPC Number: 10653160272311. qq. Model Number: DT16125, UPC Number: 10653160254751. rr. Model Number: DYNDV2435, UPC Number: 019532704366. ss. Model Number: DYNDV2536, UPC Number: 10653160353676; Model Number: DYNDV2567, UPC Number: 10653160356455. tt. Model Number: MBSIULSGD01, UPC Number: 10193489199482. uu. Model Number: DYNDV2578, UPC Number: 10653160358374. vv. Model Number: IVS3910, UPC Number: 10653160338871. ww. Model Number: CVI3880, UPC Number: 10653160272755. xx. Model Number: STCVC2020A, UPC Number: 10653160350569. yy. Model Number: STCVC2015A, UPC Number: 10653160350552. zz. Model Number: DYNJ64871, UPC Number: 019348922536.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall:
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810; d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915; e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770; f. IV SECUREMENT KIT, Model Number: DYNDV2407A; g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005; h. MIDLINE INSERTION TRAY, Model Number: CVI4340; i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011; j. MIDLINE KIT 4F SL MB, Model Number: MID0001; k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003; l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A; m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB; n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765; o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B; p. NICU PICC TRAY, Model Number: CVI3740A; q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990; r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B; s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865; t. PICC BUNDLE 5FR DL, Model Number: PICC0013; u. PICC INSERTION BUNDLE, Model Number: DT14560; v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820; w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012; x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; y. PIV BSI KIT, Model Number: BSIPIV1010; z. PIV KIT, Model Number: BSIPIV1004; aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A; bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700; cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A; dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350; ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547; ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006; gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385; hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075; ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011; jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B; kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005; ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715; mm. ULTRASOUND IV START KIT, Model Number: IV8790; nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C; oo. ULTRASOUND PIV KIT, Model Number: IVS3970; pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910; qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125; rr. USG IV START KIT, Model Number: DYNDV2435; ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567; tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01; uu. USGPIV KIT, Model Number: DYNDV2578; vv. USPIV KIT, Model Number: IVS3910; ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880; xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A; yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A; zz. VI PACK, Model Number: DYNJ64871

Product Codes/Lot Numbers:

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNDA2482, UPC Number: 10193489198188. b. Model Number: ART920, UPC Number: 10653160327899. c. Model Number: DT19810, UPC Number: 10653160285656. d. Model Number: CVI4915, UPC Number: 10653160355489. e. Model Number: IVS3770, UPC Number: 10653160328230. f. Model Number: DYNDV2407A, UPC Number: 019348981701. g. Model Number: MID0005, UPC Number: 10653160349181. h. Model Number: CVI4340, UPC Number: 10653160309475. i. Model Number: MIDST04011, UPC Number: 10653160350699. j. Model Number: MID0001, UPC Number: 10193489381627. k. Model Number: DYNJ80141MB, UPC Number: 10889942733415; Model Number: MID0003, UPC Number: 10653160349334. l. Model Number: PICC0009A, UPC Number: 10193489760231. m. Model Number: DYNJ80152MB, UPC Number: 10889942733422. n. Model Number: DYNDA2509A, UPC Number: 10193489196986; Model Number: MNS8765, UPC Number: 10653160270515. o. Model Number: DYNDC2120B, UPC Number: 10193489198270. p. Model Number: CVI3740A, UPC Number: 10653160324416. q. Model Number: IVS3990, UPC Number: 10653160345282. r. Model Number: CVI4450B, UPC Number: 10653160358428. s. Model Number: DYNDV2285, UPC Number: 10193489194548; Model Number: MNS9865, UPC Number: 10653160294436. t. Model Number: PICC0013, UPC Number: 10653160351818. u. Model Number: DT14560, UPC Number: 10653160236887. v. Model Number: CVI3805, UPC Number: 10653160265085; Model Number: CVI3820, UPC Number: 10653160273509. w. Model Number: DYNJ70141MB, UPC Number: 10889942722808; Model Number: PICC0010, UPC Number: 10653160349112; Model Number: PICC0011, UPC Number: 10653160350842; Model Number: PICC0012, UPC Number: 10653160350491. x. Model Number: DYNJ70152MB, UPC Number: 10889942722822. y. Model Number: BSIPIV1010, UPC Number: 10653160356523. z. Model Number: BSIPIV1004, UPC Number: 10193489198843. aa. Model Number: DYNJ68937A, UPC Number: 10193489111545. bb. Model Number: CVI3700, UPC Number: 10653160259763. cc. Model Number: IVS3705, UPC Number: 10653160325819; Model Number: IVS3705A, UPC Number: 10653160342885; Model Number: IVS3905A, UPC Number: 10653160344391. dd. Model Number: IVS3350, UPC Number: 10653160313045. ee. Model Number: DYNDV2465, UPC Number: 10193489110166; Model Number: DYNDV2518, UPC Number: 019532708907; Model Number: DYNDV2547, UPC Number: 10653160354246. ff. Model Number: BSIPIV1006, UPC Number: 10653160356936. gg. Model Number: DYNDV2385, UPC Number: 10193489195217. hh. Model Number: IVS4075, UPC Number: 10653160350545. ii. Model Number: BSIPIV1011, UPC Number: 10653160353317. jj. Model Number: IVS3485A, UPC Number: 10653160328612; Model Number: IVS3840, UPC Number: 10653160341994; Model Number: IVS3840A, UPC Number: 10653160344612; Model Number: IVS3940, UPC Number: 10653160342304; Model Number: IVS3940A, UPC Number: 10653160345664; Model Number: IVS3940B, UPC Number: 10653160355335. kk. Model Number: BSIPIV1005, UPC Number: 10193489198867; Model Number: DYNDA2669, UPC Number: 10193489191912; Model Number: IVS3300, UPC Number: 10653160307662; Model Number: IVS3420A, UPC Number: 10653160342205; Model Number: IVS3420B, UPC Number: 10653160359067; Model Number: IVS3495, UPC Number: 10653160316596; Model Number: IVS3505, UPC Number: 10653160323761; Model Number: IVS3655B, UPC Number: 10653160358107; Model Number: IVS3900, UPC Number: 10653160344810; Model Number: IVS3900A, UPC Number: 10653160347774; Model Number: IVS4005, UPC Number: 10653160346142. ll. Model Number: IVS3715, UPC Number: 10653160326298. mm. Model Number: IV8790, UPC Number: 019348936055. nn. Model Number: IV8635A, UPC Number: 10653160324010; Model Number: IV8635B, UPC Number: 10653160327622; Model Number: IV8635C, UPC Number: 10653160344858. oo. Model Number: IVS3970, UPC Number: 10653160343431. pp. Model Number: CVI3910, UPC Number: 10653160272311. qq. Model Number: DT16125, UPC Number: 10653160254751. rr. Model Number: DYNDV2435, UPC Number: 019532704366. ss. Model Number: DYNDV2536, UPC Number: 10653160353676; Model Number: DYNDV2567, UPC Number: 10653160356455. tt. Model Number: MBSIULSGD01, UPC Number: 10193489199482. uu. Model Number: DYNDV2578, UPC Number: 10653160358374. vv. Model Number: IVS3910, UPC Number: 10653160338871. ww. Model Number: CVI3880, UPC Number: 10653160272755. xx. Model Number: STCVC2020A, UPC Number: 10653160350569. yy. Model Number: STCVC2015A, UPC Number: 10653160350552. zz. Model Number: DYNJ64871, UPC Number: 019348922536.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2323-2023

Related Recalls

Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC010469; 6. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480; 7. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480A; 8. ADULT INTUBATION, Kit Number ACC010540; 9. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593A; 10. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593B; 11. INTUBATION TRAY, Kit Number DYNDA1847A; 12. INTUBATION TRAY (ADULT), Kit Number DYNJAA245A.

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

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Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728.

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.

Jul 25, 2025 Other Medical Devices View Details →