The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise 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.

2126–2150 of 2235

  • ModerateFDA (Devices)·Z-1626-2013·2013-07-10

    Surgical Suture Recall Due to Compromised Sterile Barrier Seal

    Surgical Instrument Service and Savings, Inc. is recalling GII QuickAnchor Plus sutures because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.

    Product
    GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1642-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Phacofragmentation System Tips

    Surgical Instrument Service And Savings, Inc. is recalling specific phacofragmentation system tips because the sterile barrier seal became compromised, allowing the product to fall out of the pouch.

    Product
    - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics¿ Mini-Flared ABS¿ Tip, 20 Degree Tip Angle, 45¿ Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics¿ Tapered ABS¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1634-2013·2013-07-10

    Surgical Instrument Recall Due to Compromised Sterile Seal

    Surgical Instrument Service And Savings is recalling Large Tear Cross Cut Rasps because the sterile seal may be compromised, allowing the product to fall out of the pouch.

    Product
    Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1623-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Carpal Tunnel Release Blades

    Surgical Instrument Service And Savings, Inc. is recalling specific carpal tunnel release blades and kits because the sterile barrier seal was compromised, potentially allowing product to fall out of the pouch.

    Product
    -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1643-2013·2013-07-10

    Surgical Instrument Service Recalls ENDOPATH Trocars Due to Compromised Sterile Seals

    Surgical Instrument Service and Savings, Inc. is recalling 259 ENDOPATH trocars and accessories because compromised sterile seals may allow product to fall out of the pouch.

    Product
    - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 - ENDOPATH Resposable Trocar w/Dilating…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1624-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls 15 Suture Instruments

    Surgical Instrument Service And Savings, Inc. is recalling 15 suture instruments because compromised seals may allow the sterile barrier to fail.

    Product
    - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1633-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls 907 Arthroscopic Instruments

    Surgical Instrument Service And Savings, Inc. is recalling 907 arthroscopic instruments because compromised sterile seals may allow product to fall out of the pouch.

    Product
    - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1625-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls 13 Medical Devices Due to Seal Compromise

    Surgical Instrument Service And Savings, Inc. is recalling 13 medical devices because compromised seals may allow products to fall out of sterile pouches.

    Product
    -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1644-2013·2013-07-10

    Harmonic ACE Curved Shear Recall Due to Compromised Sterile Seal

    Surgical Instrument Service And Savings, Inc. is recalling Harmonic ACE Curved Shears because the sterile seal may be compromised, allowing the product to fall out of the pouch.

    Product
    Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1641-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Arthroscopic Cannulas Due to Seal Defect

    Surgical Instrument Service And Savings, Inc. is recalling 73 arthroscopic cannulas because a compromised seal may allow the product to fall out of the sterile pouch.

    Product
    - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631 - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-616-2013·2013-07-03

    Hospira Recalls 20% Dextrose Injection Due to Possible Leaking Bags

    Hospira is voluntarily recalling 20% Dextrose Injection, USP, due to possible leaking bags that may compromise sterility.

    Product
    20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-617-2013·2013-07-03

    Hospira Recalls 0.9% Sodium Chloride Irrigation Due to Sterility Concerns

    Hospira is voluntarily recalling 0.9% Sodium Chloride Irrigation bags due to possible leaking that compromises sterility.

    Product
    0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-618-2013·2013-07-03

    Hospira Recalls 1.5% Glycine Irrigation Due to Sterility Concerns

    Hospira is voluntarily recalling 1.5% Glycine Irrigation, USP, 3000 mL, due to possible leaking bags that may compromise sterility.

    Product
    1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-615-2013·2013-07-03

    Hospira Recalls 5% Dextrose and 0.45% Sodium Chloride Injection Due to Sterility Concerns

    Hospira Inc. is voluntarily recalling 74,256 units of 5% Dextrose and 0.45% Sodium Chloride Injection due to possible leaking bags that may compromise sterility.

    Product
    5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-612-2013·2013-07-03

    Hospira Recalls 70% Dextrose Injection Due to Possible Leaking Bags

    Hospira is voluntarily recalling 14,706 units of 70% Dextrose Injection USP due to possible leaking bags that may compromise sterility.

    Product
    70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1543-2013·2013-06-19

    Utah Medical Products Recalls Deltran Disposable Pressure Transducer Kits

    Utah Medical Products is recalling 1,800 Deltran Disposable Pressure Transducer Kits due to complaints regarding the packaging integrity of the sterile devices.

    Product
    Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2013·2013-05-15

    Baxter Recalls Non-DEHP Y-Type Catheter Extension Sets Due to Sterility Compromise

    Baxter Healthcare is recalling 228,200 units of Non-DEHP Y-Type Catheter Extension Sets because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1158-2013·2013-05-01

    Teleflex Medical Recalls Belly Bag Urine Collection Bags Due to Packaging Concerns

    Teleflex Medical is recalling 190,103 sterile Belly Bag Urine Collection Bags with Hip Belts because the sterile packaging may be compromised.

    Product
    Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1134-2013·2013-04-24

    Edwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes

    Edwards Lifesciences is recalling 5,472 units of Model 9100CR23 Crimpers because holes in the sterile barrier pouch may compromise sterility.

    Product
    Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2013·2013-04-24

    Edwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes

    Edwards Lifesciences is recalling 6,117 units of Model 9100CR26 Crimpers because holes in the sterile barrier pouch may compromise sterility.

    Product
    Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2013·2013-04-10

    LeMaitre Stent Guide Recalled Due to Compromised Sterility

    LeMaitre Vascular, Inc. is recalling LeMaitre Stent Guide strips because they were not sealed correctly during manufacturing, compromising their sterility.

    Product
    LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2013·2013-04-10

    LeMaitre Vascular Recalls Glow 'N Tell Tape Due to Sterility Compromise

    LeMaitre Vascular is recalling Glow 'N Tell 20 cm Tape because manufacturing defects compromised the sterility of the devices.

    Product
    Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA)…
    Category
    Medical Device
    Distribution
    Distributed nationwide