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.

226–250 of 2228

  • HighFDA (Devices)·Z-1698-2023·2023-06-14

    Magic3 Go Female Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard Inc is recalling Magic3 Go female intermittent urinary catheters worldwide due to a manufacturing defect where the resealing label can separate from the product pouch, potentially compromising product sterility.

    Product
    Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1701-2023·2023-06-14

    HydroSil Go Catheters Recalled for Packaging Sterility Risk

    C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters because the resealing label may separate from the foil pouch, potentially compromising product sterility. The recall affects 308,520 devices worldwide.

    Product
    HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0777-2023·2023-06-07

    Sodium Chloride Injection Recalled Due to Storage Temperature Exposure Risk

    Fresenius Medical Care is recalling Sodium Chloride 0.9% Injection due to potential storage temperature exposure that may compromise sterility. The affected product includes 53,424 bags distributed to clinics in South Carolina, North Carolina, and Virginia.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-1646-2023·2023-06-07

    Medline sterile surgical procedure packs recalled due to water damage

    Medline Industries is recalling three sterile surgical procedure packs that were damaged by water, compromising their sterility. The recall affects 342 packs distributed in California.

    Product
    Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1611-2023·2023-05-24

    Teleflex D-Stat Flowable Hemostat Recalled for Expired Diluent Vial

    Teleflex is recalling D-Stat Flowable Hemostat units with expired diluent vials that cannot assure sterility. No illnesses or injuries have been reported.

    Product
    Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0542-2023·2023-05-03

    Dianeal Low Calcium Dialysis Solution Recalled for Potential Sterility Loss

    Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution nationwide due to potential leaks from the container that could compromise sterility. Affected patients should contact their healthcare provider.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2023·2023-04-05

    Alcon Custom Pak Surgical Procedure Packs Recalled for Incomplete Seals

    Alcon Research is recalling 1,035 Custom Pak Surgical Procedure Packs with incomplete seals that affect sterility. These packs were distributed to surgical facilities in 14 US states.

    Product
    Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 1913
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1200-2023·2023-03-08

    CustomEyes kits recalled due to potential sterility compromise

    Beaver Visitec International is recalling 4640 units of CustomEyes kits because packaging may contain open seals that could compromise product sterility. Affected units were distributed to 26 U.S. states and internationally.

    Product
    CustomEyes kits
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-1118-2023·2023-02-22

    Surgical Convenience Kits Recalled Due to Compromised Sterility of External Wrapping

    Medline Industries is recalling 630 surgical convenience kits because the perforated bag design fails to maintain sterility of the outer wrapping, though internal contents remain sterile.

    Product
    Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PROD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2023·2023-02-22

    Surgical kits recalled due to compromised sterile wrapping

    Medline Industries is recalling multiple CENTURION MEDICAL PRODUCTS surgical kits because perforated packaging compromises the sterile barrier. Only contents inside the kit wrapping maintain sterility.

    Product
    Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2023·2023-02-22

    Surgical convenience kits recalled for compromised external packaging sterility

    Medline Industries is recalling 1,588 surgical kits nationwide due to a perforated bag design that prevents the outside of the kit wrapping from remaining sterile.

    Product
    Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2023·2023-02-22

    Surgical Instrument Trays Recalled for Compromised Outer Bag Sterility

    Medline Industries recalls CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAYS due to a perforated outer bag that fails to maintain sterility. While the inner contents remain sterile, the compromised outer bag could contaminate instruments during surgical procedures.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2023·2023-02-22

    Surgical angio port kits recalled for compromised sterile barrier

    Medline is recalling 30 units of surgical angio port kits due to a perforated outer bag that prevents the external packaging from being sterile, creating a contamination risk during surgical use.

    Product
    Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2023·2023-02-22

    Medline Surgical Shoulder Suspension Kits Recalled for Sterility Compromise

    Medline is recalling 1,280 SHOULDER SUSPENSION surgical kits nationwide due to a defective perforated bag that fails to maintain sterility on the kit's exterior, potentially compromising the sterile contents inside.

    Product
    Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2023·2023-02-22

    Surgical convenience kits recalled for sterile barrier defect

    Medline Industries recalls 1537 Lab Draw Kits (Reorder #DYNDH1641A, Lot 22HMH339) distributed nationwide due to a perforated outer bag that cannot maintain sterility, compromising the protective barrier.

    Product
    Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2023·2023-02-22

    Surgical Convenience Kits Recalled for Outer Wrapping Sterility Defect

    Medline is recalling 1376 surgical convenience kits nationwide due to a packaging defect that compromises the sterility of the outer wrapping. Only the kit contents remain sterile.

    Product
    Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1115-2023·2023-02-22

    Surgical Tracheostomy Kit Recalled Due to Perforated Outer Wrapping Compromising Sterility

    Medline Industries has recalled 120 units of Centurion Medical Products Tracheostomy Tray due to a perforated outer bag that prevents the exterior from remaining sterile, though the kit contents remain sterile.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2023·2023-02-22

    Surgical Convenience Kits Recalled for Compromised Sterility Assurance

    Medline Industries is recalling surgical convenience kits with reorder number DYNJCD0063 due to a perforated bag that fails to keep the kit's outer wrapping sterile. Affected units were distributed nationwide.

    Product
    Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1109-2023·2023-02-22

    Surgical convenience kits recalled for compromised sterility packaging

    MEDLINE PAIN TRAY surgical convenience kits (120 units, Lot #22EBA798) are recalled nationwide because a perforated outer bag compromises the sterile barrier. Only the contents inside the kit's inner wrapping remain sterile.

    Product
    Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Blade Packaging Puncture

    Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1095-2023·2023-02-15

    Sterile Ophthalmic Procedure Trays Recalled for Packaging Integrity Risk

    Medline Industries is recalling sterile ophthalmic procedure trays because blades in the kits can puncture the outer foil packaging, potentially compromising sterility. The recall affects 1,200 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: LS MS PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Packaging Compromise

    Medline Industries recalls sterile pelviscopy trays because blades inside may puncture the protective foil packaging, potentially compromising sterility. 316 units distributed worldwide are affected.

    Product
    Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Packaging Puncture

    Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2023·2023-02-15

    Sterile Surgical Trays Recalled for Blade Puncture Risk

    Medline Industries recalls sterile surgical procedural trays because blades inside could puncture the outer sterile packaging, potentially compromising kit sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTEREC
    Category
    Medical Device
    Distribution
    Distributed nationwide