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.

1926–1950 of 2235

  • SevereFDA (Devices)·Z-0357-2015·2014-12-10

    Customed Liposuction Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 20 Liposuction Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Liposuction Pack, catalog #900-2656 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0388-2015·2014-12-10

    Customed Recalls Pery GYN Surgical Packs Due to Sterility Compromise

    Customed, Inc. is recalling 354 Pery GYN Surgical Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Pery GYN Surgical Pack, Catalog number 900-548A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0389-2015·2014-12-10

    Customed Laparoscopy Cholecystectomy Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 192 units of Laparoscopy Cholecystectomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0377-2015·2014-12-10

    Customed Cesarean Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 654 Cesarean Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0415-2015·2014-12-10

    Customed C-Section Pack Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 122 C-Section Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    C-Section Pack, Catalog # 900-998 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0490-2015·2014-12-10

    Gambro Recalls Polyflux Dialyzers Due to Potential Packaging Tears

    Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.

    Product
    Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2015·2014-12-10

    Teleflex Medical Recalls Aquapak Nebulizer Adaptors Due to Seal Integrity Concerns

    Teleflex Medical is recalling Aquapak nebulizer adaptors because packaging seals may be open or weak, potentially affecting the sterility of the device.

    Product
    Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0282-2015·2014-12-03

    Hospira Recalls 5% Dextrose and 0.9% Sodium Chloride Injection Bags

    Hospira is recalling 340,272 bags of 5% Dextrose and 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0283-2015·2014-12-03

    Hospira Recalls Lactated Ringer's Injection Due to Sterility Concerns

    Hospira is recalling 6,193,416 bags of Lactated Ringer's Injection because potential punctures may compromise sterility and cause leaks.

    Product
    Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2014·2014-11-26

    Medtronic Recalls Sterile Mouse Bags Due to Sterility Control Issues

    Medtronic Navigation is recalling sterile mouse bags because returned devices may not have been properly examined for damage that could compromise sterility.

    Product
    BAG 9732315 MOUSE STERILE 15 PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2014·2014-11-26

    Medtronic Recalls Non-Invasive Shunt Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 non-invasive shunt kits because returned devices were not adequately inspected for damage that could compromise sterility.

    Product
    SHUNT KIT 9733605 NON-INVASIVE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2014·2014-11-26

    Medtronic Recalls Single-Use Navigation Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 single-use, disposable navigation devices because returned units were not adequately examined for damage that could compromise sterility.

    Product
    UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2014·2014-11-26

    Medtronic Recalls Biopsy Needle Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 biopsy needle kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    BIOPSY NEEDLE KIT, 9733068, PASSIVE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2014·2014-11-26

    Medtronic Recalls Disposable Surgical Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 single-use disposable devices because returned items were not adequately inspected for damage that could compromise sterility.

    Product
    DISP 9730950 STRL SPHERE, 1 PK INSERT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1580-2014·2014-11-26

    Medtronic Recalls Sterile Drill Bits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile drill bits because returned devices may not have been properly examined for damage that could compromise sterility.

    Product
    BIT 9733516 2.9mm DRILL STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1588-2014·2014-11-26

    Medtronic Recalls Sterile O-Arm Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile O-Arm devices because returned units may not have been properly inspected for damage that could compromise sterility.

    Product
    MOUSE 9732721 STERILE O-ARM 10PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1589-2014·2014-11-26

    Medtronic Recalls AxIEM CR Tumor Resection Devices Due to Sterility Concerns

    Medtronic Navigation is recalling 26,674 AxIEM CR tumor resection devices because returned units may not have been properly inspected for damage that could compromise sterility.

    Product
    PACK 9731975 TUMOR RESECTION AXIEM CR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1592-2014·2014-11-26

    Medtronic Recalls Sterile Percutaneous Pins Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    PIN, 9733235, 100MM, STERILE, PERC REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1598-2014·2014-11-26

    Medtronic Recalls Traj Guide Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.

    Product
    TRAJ GUIDE KIT, 9733066, BIOPSY, INT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1601-2014·2014-11-26

    Medtronic Recalls Tumor Resection Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    TUMOR RESECTION KIT 9733608 SKULL MOUNT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1597-2014·2014-11-26

    Medtronic Recalls Traj Guide Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.

    Product
    TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0100-2015·2014-10-29

    Gyrus Medical Recalls Sterile Surgical Forceps and Scissors Due to Seal Defects

    Gyrus Medical is recalling specific sterile surgical forceps and scissors because a packaging anomaly may compromise the sterile barrier.

    Product
    GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps…
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-0066-2015·2014-10-22

    Arrow Select Kits Recalled Due to Potential Sterility Compromise

    Arrow International is recalling Select Kits and Maximal Barrier Precautions Kits containing BD Posiflush syringes because open seals may compromise sterility.

    Product
    Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
    Category
    Medical Device
    Distribution
    Distributed nationwide