The Recall Desk

FDA (Devices) recall action 94136

MEDLINE INDUSTRIES, LP - Northfield recalled 29 products on 2024-04-10

The FDA (Devices) publishes a recall like this one as 29 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 29 pages.

Products
29
Announced
2024-04-10
Critical
0
Units
1,158,478

Why these products were recalled

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 29

  • HighFDA (Devices)··2024-04-10

    Medline Centurion surgical scissors recalled due to weak seals

    Medline Industries is recalling Centurion surgical scissors due to potentially weak seals that may compromise sterility. Users cannot reliably detect the defect, creating risk if compromised instruments are used in surgery.

    Product
    Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion Sterile Trach Brush Recalled Due to Weak Seal

    Medline Industries is recalling 1700 Centurion Sterile Trach Brush devices due to a potential weak seal that may breach product sterility if the seal fails. The defect may not be obvious to users.

    Product
    Centurion STERILE TRACH BRUSH, Product Code 6225ST
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion Surgical Instrument Kits Recalled for Potentially Weak Seals

    Medline is recalling Centurion manual surgical kits with potentially weak seals that may result in a breach of sterility if the seal fails. The weak seal may not be detectable by all users.

    Product
    Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e)…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion Manual Surgical Kits Recalled Due to Weak Seal

    Medline Industries is recalling Centurion manual surgical kits due to weak seals that may compromise sterility. Approximately 7,950 units were distributed nationwide and internationally.

    Product
    Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion Dental Kits Recalled for Weak Seal Risk

    Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.

    Product
    Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Medline Centurion Manual Surgical Kits Recalled for Weak Seal Risk

    Medline Industries is recalling 1700 units of Centurion Manual surgical kits due to potential weak seals that could compromise sterility. The weak seal may not be detectable by users.

    Product
    Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Medline Centurion surgical kits recalled due to weak seal

    Medline Industries is recalling Centurion manual surgical kits because they may have weak seals that could compromise product sterility. The defect may not be noticeable to users before the kits are used.

    Product
    Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Laryngeal Mirror Weak Seal May Breach Sterility

    Medline is recalling Centurion STERILE #5 Laryngeal Mirrors due to weak packaging seals that may not be detectable by users. The defect could result in a breach of the product's sterility if the seal fails.

    Product
    Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Sterile Rubber Band Recall for Weak Seal Risk

    Medline Industries, LP is recalling Centurion STERILE #16 rubber bands because the package seal may be weak, potentially compromising product sterility. The defect may not be visible to users before opening.

    Product
    Centurion STERILE #16 RUBBER BAND, Product Code EB16
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Medline Centurion Surgical Retractors Recalled for Potential Sterility Breach

    Medline is recalling Centurion surgical retractor kits (760 units) due to a weak seal that could compromise sterility if it fails. The weakness may not be detectable by users.

    Product
    Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion Scalpel Handles Recalled Due to Weak Seal Risk

    Medline Industries is recalling Centurion scalpel handle kits due to weak seals that may compromise sterility. Users cannot always detect the defect.

    Product
    Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Suture Removal and Staple Remover Kits Recalled for Weak Seal

    Medline Industries is recalling suture removal trays and staple remover kits due to weak seals that may compromise product sterility. Approximately 23,290 units were distributed in the US, Panama, and Canada.

    Product
    Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c)…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion PICC Line Securement Kit Recalled for Weak Seal

    MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.

    Product
    Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion Hemostat Kits Recalled Due to Weak Seal Sterility Breach Risk

    Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.

    Product
    Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion Manual Uterine Dilator Surgical Kits Recalled for Weak Seal

    MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.

    Product
    Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Medline wire cut scissors may have weak seal compromising sterility

    Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.

    Product
    MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Medline Swabsticks PVP Product Recalled for Weak Seal Risk

    Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.

    Product
    MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Medline Pediatric Magill Catheter Recalled for Weak Seal Risk

    Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.

    Product
    Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion Curette kits recalled for weak seals potentially compromising sterility

    Medline Industries is recalling Centurion Curette kits because some may have weak seals that could compromise product sterility. The weak seal may not be detectable during inspection.

    Product
    Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Medline Centurion Surgical Forceps Kits Recalled for Defective Seals

    Medline Industries recalls 274,410 units of Centurion and Medline branded surgical forceps kits for potentially weak seals that could compromise sterility and may not be detectable during use.

    Product
    Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e)…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion Surgical Hook Kits Recalled Due to Weak Seal

    Medline Industries is recalling 1,520 Centurion surgical hook kits worldwide due to weak seals that may compromise sterility. The seal defect may not be detectable by users.

    Product
    Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Sterile tape/pen pack recalled for potential sterility breach

    Medline M1S0179 sterile tape/pen packs may have weak seals that could compromise product sterility. The weakness may not be visible during normal inspection.

    Product
    MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion Ear Speculum Sets Recalled for Weak Seal and Sterility Risk

    Medline Industries is recalling Centurion ear speculum sets due to weak seals that could compromise sterility. The defect may not be detectable by users and could allow contamination if the seal fails.

    Product
    Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
    Category
    Distribution
    0 states