The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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.

126–150 of 2228

  • HighFDA (Devices)·Z-1469-2025·2025-04-09

    Otopore Outer Ear Dressings Recalled for Compromised Sterile Packaging Seals

    Stryker Corporation is recalling 182,344 Otopore Cylinder Standard outer ear dressings due to potential defects in blister seals that may compromise sterility. Bubbles in packaging seals indicate the sterile barrier is breached.

    Product
    Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0257-2025·2025-03-19

    Sodium Chloride Injection Recalled for Potential Sterility Compromise

    Nephron Sterile Compounding Center is recalling Sodium Chloride Injection 9% due to potential leakage at the IV bottle port, which could compromise sterility. Affected lots were distributed nationwide.

    Product
    Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1013-2025·2025-01-29

    Wolf-Pak Dressing Change Kits Recalled Due to Package Defects

    Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2025·2025-01-29

    Dressing change kits recalled due to packaging defect compromising sterility

    Trinity Sterile is recalling Dressing Change Kits with ChloraPrep and HaloGUARD due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed across multiple states.

    Product
    Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2025·2025-01-29

    Dressing Change Tray Recalled Due to Potential Package Sterility Compromise

    Trinity Sterile's Dressing Change Tray (Model TM6180CP, Lot 600032) is recalled because of a potential hole in the package that could compromise sterility. The recall affects 280 units distributed across Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2025·2025-01-29

    Dressing Change Kit Recalled Due to Package Integrity Concern

    Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2025·2025-01-29

    Dressing Change Kits Recalled for Potential Package Sterility Compromise

    Trinity Sterile is recalling Wolf-Pak Dressing Change Kits due to a potential hole in the package that could compromise the sterility of the medical kit. Lot #600022 (3,960 units) distributed nationwide.

    Product
    Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Componen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2025·2024-12-04

    Karl Storz surgical instruments recalled for sterility barrier defect

    Karl Storz Endoscopy has recalled 105 surgical instruments with holes in their sterility barriers. The defect may compromise product sterility; affected devices were distributed nationwide and internationally.

    Product
    4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2025·2024-11-27

    Maquet Cardiovascular Recalls Acrobat-i Positioners Due to Sterility Concerns

    Maquet Cardiovascular is recalling 14,338 Acrobat-i Positioners because manufacturing deviations compromised the sterile barrier, meaning sterility cannot be assured during the product's 2-year shelf life.

    Product
    Acrobat-i Positioner. Model Number C-XP-5000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0227-2025·2024-11-13

    Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination

    Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465,
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0280-2025·2024-11-06

    Surgical Screwdriver Battery Pack Recalled for Foreign Material Contamination

    Pro-Dex Inc is recalling KLS Martin battery packs for surgical drivers distributed in Florida because the sterile packaging may contain Tyvek shavings that could compromise device sterility.

    Product
    KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0283-2025·2024-11-06

    West Pharmaceutical Recalls Vial2Bag Advanced Devices Due to Sterile Barrier Risk

    West Pharmaceutical Services is recalling Vial2Bag Advanced 20mm Admixture Devices because heat exposure during shipping may have compromised the sterile barrier.

    Product
    Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the rec
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-0177-2025·2024-10-30

    Medline Medical Procedure Convenience Kits Recalled for Sterility Risk

    Medline is recalling specific medical procedure convenience kits because a packaging defect could allow the use of non-sterile products if the vendor seal is opened.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Sterility Compromise

    Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0144-2025·2024-10-30

    Smiths Medical Recalls 15mm Double Swivel Connectors Due to Packaging Concerns

    Smiths Medical is recalling 34,141 units of 15mm Double Swivel Connectors worldwide due to uncertainty in the seal integrity of the sterile packaging.

    Product
    smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0058-2025·2024-10-23

    Merit Medical Recalls Monarch Inflation Devices Due to Sterile Barrier Breaches

    Merit Medical Systems is recalling 41,411 Monarch Inflation Devices because manufacturing defects caused holes in the sterile barrier.

    Product
    Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to mea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3258-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug expires before labeled expiration date

    Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3260-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug Recalled for Premature Expiration

    Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3084-2024·2024-09-25

    Baxter pharmaceutical compounding inlets recalled for particulate matter contamination

    Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.

    Product
    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3147-2024·2024-09-25

    Boston Scientific Recalls Flexima APDL Drainage Catheter Systems Due to Sterility Risk

    Boston Scientific is recalling 89 units of Flexima APDL Drainage Catheter Systems because holes in the sterile barrier may compromise device sterility.

    Product
    Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3097-2024·2024-09-18

    Smith & Nephew Tendon Staples Recalled for Compromised Packaging Sterility

    Smith & Nephew is recalling 2,961 units of ROTATION MEDICAL TENDON STAPLES due to improper outer foil pouch sealing that may compromise product sterility. No injuries have been reported.

    Product
    ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3096-2024·2024-09-18

    Smith & Nephew Recalls Rotation Medical Tendon Staples Due to Seal Defects

    Smith & Nephew is recalling Rotation Medical Tendon Staples because packaging defects may compromise sterility. The recall affects 6,465 units distributed worldwide.

    Product
    ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3095-2024·2024-09-18

    Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears Recalled for Packaging Seal

    Medline is recalling 46 units of reprocessed Ethicon Harmonic ACE+7 Shears due to a potential incomplete seal on the packaging tray.

    Product
    Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2945-2024·2024-09-11

    Heparin Gore Viabahn VBX Endoprosthesis Recalled for Packaging Defects

    W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.

    Product
    Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2946-2024·2024-09-11

    W L Gore Recalls Heparin Viabahn VBX Endoprosthesis Due to Packaging Defects

    W L Gore & Associates is recalling specific lots of Heparin, Gore Viabahn VBX Balloon Expandable Endoprosthesis because packaging defects may compromise sterility and heparin activity.

    Product
    Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *Fo
    Category
    Medical Device
    Distribution
    Distributed nationwide