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.

1976–2000 of 2235

  • ModerateFDA (Devices)·Z-2248-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Screws because they failed a leak test due to damage of the inner cavity.

    Product
    6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2244-2014·2014-08-27

    Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed leak tests due to inner cavity damage.

    Product
    Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2247-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Trauma Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Trauma Screws because they failed leak tests due to inner cavity damage.

    Product
    6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Devices)·Z-2080-2014·2014-07-30

    Stryker Recalls Disposable StrykeFlow Tips Due to Sterility Concerns

    Stryker Endoscopy is recalling 496 boxes of Disposable StrykeFlow Tips because a deformed blister pouch could compromise the product's sterility.

    Product
    Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1442-2014·2014-07-23

    CareFusion Recalls ChloraPrep Applicators Due to Sterility Concerns

    CareFusion is recalling 23,000 ChloraPrep applicators because immediate product pouches may not be properly sealed, potentially compromising sterility.

    Product
    ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2014·2014-07-16

    Vascular Technology Recalls Sterile Doppler Probes Due to Barrier Penetration

    Vascular Technology, Inc. is recalling 34 sterile Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.

    Product
    07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2035-2014·2014-07-16

    Zimmer M/L Taper Hip Prosthesis Recalled Due to Black Residue

    Zimmer, Inc. is recalling M/L Taper Hip Prostheses with Kinectiv Technology because black residue was observed in the sterile pouches.

    Product
    Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2033-2014·2014-07-16

    Zimmer M/L Taper Hip Stem Recall Due to Black Residue

    Zimmer, Inc. is recalling M/L Taper Hip Stems because black residue was observed in the sterile pouches. The recall covers 1,487 units distributed worldwide.

    Product
    Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1952-2014·2014-07-09

    Medical Action Industries Recalls Sterile Suture Sets Due to Seal Defects

    Medical Action Industries is recalling sterile suture sets because incomplete seals may compromise sterility. The recall involves 474 cases distributed across 15 states.

    Product
    Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1951-2014·2014-07-09

    Medical Action Industries Recalls Sterile Laceration Kits Due to Seal Defects

    Medical Action Industries is recalling sterile laceration and suture removal kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1954-2014·2014-07-09

    Medical Action Industries Recalls Max Barrier Kits Due to Seal Defects

    Medical Action Industries is recalling Max Barrier Kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1955-2014·2014-07-09

    Medical Action Industries Recalls Safety Laceration Kits Due to Seal Defects

    Medical Action Industries is recalling Safety Laceration Kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1953-2014·2014-07-09

    Medical Action Industries Recalls Port-A-Cath Trays Due to Seal Defects

    Medical Action Industries is recalling Port-A-Cath Trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1950-2014·2014-07-09

    Medical Action Industries Recalls Sterile Laceration Trays Due to Seal Defects

    Medical Action Industries is recalling sterile laceration trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1957-2014·2014-07-09

    Medical Action Industries Recalls Laceration Kits Due to Seal Defects

    Medical Action Industries is recalling sterile laceration kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1956-2014·2014-07-09

    McKesson Medi-Pak Laceration Trays Recalled for Incomplete Sterile Seals

    Medical Action Industries is recalling 474 cases of McKesson Medi-Pak Laceration Trays because some sterile kits may have incomplete seals that could compromise sterility.

    Product
    McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1782-2014·2014-06-18

    Cooper Surgical Tampa Catheter Recalled for Potential Sterility Compromise

    CooperSurgical is recalling 1,180 units of the Tampa Catheter because unsealed pouches may compromise the device's sterility.

    Product
    Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2014·2014-06-11

    FDA Recalls Bard Ventralight ST Mesh Due to Potential Sterility Compromise

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1694-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterility Compromise

    Davol, Inc. is recalling Bard Ventralight ST Mesh because the sterile inflation assembly pouch may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2014·2014-06-11

    Bard Composix LIP Mesh Recall Due to Potential Sterility Compromise

    Davol, Inc. is recalling Bard Composix LIP Mesh with Echo PS because the sterile inflation assembly packaging may be open or have a weak seal.

    Product
    Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Pouch Seal Failure

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS due to potential pouch seal failures that could compromise sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1696-2014·2014-06-11

    Bard Ventralight ST Mesh Recalled for Potential Sterile Pouch Seal Defects

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may have an open or weak seal.

    Product
    Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1695-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Failure

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 8" Circle because the sterile pouch holding the inflation assembly may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2014·2014-06-11

    Bard Ventralight ST Mesh Recall for Potential Sterile Pouch Seal Issues

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile inflation assembly pouch may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide