The Recall Desk

Hazard

Leakage recalls

718 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
718
Critical
4
Severe
174
Most recent
2026-10-07

Of the 718 leakage recalls we have scored against our rubric, 4 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 174 (24%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all leakage recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

451–475 of 718

  • SevereFDA (Devices)·Z-1837-2018·2018-05-23

    Medtronic Endo GIA Universal Bypass Kits Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA Universal Bypass Kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1849-2018·2018-05-23

    Medtronic Recalls Bariatric Staplers Due to Missing Sled Component

    Medtronic is recalling specific bariatric stapler kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403) (3) BOX PST03533 KIT APP STAPLER (Item Number: PST03403) Product Usage: The Endo GIA universal and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1839-2018·2018-05-23

    Medtronic Recalls Bypass Kits Due to Missing Stapler Component

    Medtronic is recalling 171,271 Endo GIA Bypass Kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1831-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal and Universal XL staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1833-2018·2018-05-23

    Medtronic Endo GIA Universal Stapler Kits Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal stapler kits because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX BOX1073180APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180APPE1 APPENDIX KIT ZAMS) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may cause staple line failure, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2018·2018-05-23

    Medtronic Endo GIA Stapler Recall Due to Missing Sled Component

    Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2018·2018-05-23

    Medtronic Endo GIA Universal Stapler Sleeves Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal stapler sleeves and bypass units because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 BYPASS AIWA CLINIC Item Number: PST04090 BYPASS AIWA CLINIC Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2018·2018-05-16

    Parker Laboratories Recalls Sterile Ultrasound Gel for Potential Seal Leaks

    Parker Laboratories, Inc. is recalling Sterile Aquasonic 100 Ultrasound Transmission Gel because the packet seals may leak.

    Product
    Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0695-2018·2018-03-07

    DePuy Mitek Recalls FMS Gravity Tube Sets Due to Leakage

    DePuy Mitek is recalling FMS Gravity Tube Sets because they may leak at the bulb and tube connection during arthroscopic procedures.

    Product
    1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0245-2018·2018-02-07

    Neutrogena Holiday Trays Recalled for Container Leakage

    Johnson & Johnson is recalling Neutrogena Elevated 4-Holiday Trays due to defective containers that leak propellant and product.

    Product
    Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2018·2018-01-31

    Baxter Recalls MARS Treatment Kits Due to Albumin Circuit Leakage

    Baxter Healthcare is recalling 186 MARS Treatment Kits because of a defect in the albumin circuit that causes leakage. The issue stems from an inadequate adhesive connection in the tubing.

    Product
    MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0207-2018·2017-12-13

    BD Precision Glide Needles Recalled for Hub Damage and Leakage

    Becton Dickinson is recalling 2,598,000 BD Precision Glide Needles due to hub damage that can cause breakage or leakage during use.

    Product
    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2018·2017-11-29

    Abbott Peristaltic Head Tubing Recalled for Potential Leaking

    Abbott Laboratories is recalling Peristaltic Head tubing for clinical chemistry systems due to a manufacturing issue that may cause the tubing to leak.

    Product
    Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1016-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling a specific lot of fentanyl and bupivacaine injection due to a lack of assurance of sterility and potential for leaking.

    Product
    fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1034-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine Infusion Bags

    SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine infusion bags due to a lack of assurance of sterility and potential for leaking.

    Product
    fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1008-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of fentanyl injection bags due to a lack of assurance of sterility and potential for leaking.

    Product
    fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1014-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine infusion bags due to a lack of assurance of sterility and potential for leaking.

    Product
    fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1029-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Phenylephrine 200 mg in 0.9% Sodium Chloride 250 mL injections due to a lack of assurance of sterility and potential for leaking.

    Product
    PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40
    Category
    Drug
    Distribution
    Distributed nationwide