The Recall Desk

Hazard

Non Sterile Product recalls

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

What the numbers show

Total
23
Critical
0
Severe
6
Most recent
2025-12-03

Of the 23 non sterile product recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (26%) are Severe.

Which agencies issued them

About this hazard tag

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

1–23 of 23

  • HighFDA (Drugs)·D-0179-2026·2025-12-03

    Saline nasal spray recalled over microbial contamination with Pseudomonas lactis

    Medical Products Laboratories is recalling 41,328 bottles of Walgreens Saline Nasal Spray with Xylitol over microbial contamination identified as Pseudomonas lactis.

    Product
    Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0505-2025·2025-07-09

    Zicam Nasal AllClear swabs recalled over fungal contamination of swabs

    Zicam Nasal AllClear swabs are being recalled because of fungal contamination of the nasal swabs. All lots are affected, covering 13,632 cartons.

    Product
    ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0506-2025·2025-07-09

    Orajel Baby teething swabs recalled over fungal contamination of swabs

    Orajel Baby Cooling Swabs for Teething are being recalled because of fungal contamination of the infant oral swabs. All lots are affected, covering 695,880 cartons.

    Product
    Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0504-2025·2025-07-09

    Zicam cold remedy nasal swabs recalled over fungal contamination

    Zicam Cold Remedy Medicated Nasal Swabs are being recalled because of fungal contamination of the swabs. All lots are affected, covering 3,374,918 cartons.

    Product
    ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2025·2024-10-30

    Medline Tubal Ligation Kits Recalled for Potential Sterility Compromise

    Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.

    Product
    Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2025·2024-10-30

    Medline Centurion Medical Procedure Kits Recalled for Sterility Risk

    Medline is recalling 168 Centurion medical procedure kits because packaging defects may allow non-sterile product use if the vendor seal is compromised.

    Product
    Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2025·2024-10-30

    Medline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk

    Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2025·2024-10-30

    Medline medical procedure kits recalled for potential sterility breach

    Medline medical procedure convenience kits with certain breather pouches may lose sterility if the vendor seal is opened. Approximately 5,972 units were distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2025·2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile product risk

    Medline is recalling four types of medical procedure convenience kits that may contain non-sterile products if the pouch seal is opened. Approximately 197 units were distributed nationwide and internationally.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2025·2024-10-30

    Medline dental pack may contain non-sterile product due to packaging defect

    Medline dental procedure kits may contain non-sterile product if the breather pouch seal is compromised. The recall affects 165 units distributed in the US, Canada, and Panama.

    Product
    Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2025·2024-10-30

    Medline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk

    Medline is recalling 194 drape packs from breather pouch lot 323080002 that may be non-sterile if the seal is opened. The kits were distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2025·2024-10-30

    Medline Medical Procedure Kits Recalled Due to Non-Sterile Product Risk

    Medline is recalling certain convenience kits for medical procedures due to potential non-sterile product risk if the breather pouch seal is compromised. The recall affects 51 units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2025·2024-10-30

    Medline chest tube insertion tray may contain non-sterile equipment due to breached seal

    Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.

    Product
    Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2025·2024-10-30

    Medline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk

    Medline is recalling 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0162-2025·2024-10-30

    Medline Central Catheter Insertion Kit Recalled for Potential Non-Sterile Packaging

    Medline CENTRAL CATHETER INSERTION KIT (Ref CVI680C) is being recalled because certain units may be non-sterile due to potential seal failures in packaging. The recall affects 1,180 units distributed in the US, Canada, and Panama.

    Product
    Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1135-2023·2023-09-06

    FDA Recalls Heparin IV Bags Due to Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling 577 bags of heparin IV solution (2500 units/500mL) nationwide due to lack of validation data for sanitization cycles, which could compromise sterility assurance.

    Product
    heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0809-2023·2023-05-10

    Atkins Dark Chocolate Royale Protein Shakes Recalled for Contamination

    Simply Good Foods Co. is recalling Atkins Dark Chocolate Royale Protein Rich Shakes due to contamination that rendered the product non-sterile, creating potential for spoilage.

    Product
    Atkins Dark Chocolate Royale Protein Rich Shakes, NET WT. 44 oz (4 / 11oz) 4 Tetra packs per carton, UPC 637480065108, Distributed exclusively by Simply Good Foods USA, Inc. 1 Denver, CO 80202 1-800-6-ATKINS.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0377-2022·2022-01-26

    SENNA Syrup unit-dose cups recalled for microbial contamination

    Lohxa, LLC is recalling SENNA Syrup (sennosides) 8.8 mg/5 mL unit-dose cups due to microbial contamination of the non-sterile product. The recall affects Lot #AM1115S with expiration date 01/2023, distributed nationwide.

    Product
    SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2022·2021-12-29

    OTC Expectorant Recall: Microbial Contamination in Rompe Pecho

    Efficient Laboratories is recalling Rompe Pecho guaifenesin expectorant in 4 fl oz and 6 fl oz bottles due to microbial contamination of non-sterile products. The affected product was distributed nationwide.

    Product
    ROMPE PECHO — ROMPE PECHO (GUAIFENESIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0293-2022·2021-12-29

    OTC Cough and Cold Drug Recalled for Microbial Contamination

    Efficient Laboratories is recalling approximately 4,026 bottles of Rompe Pecho Max Multi-Symptoms cough and cold medicine nationwide due to potential microbial contamination of the non-sterile product.

    Product
    ROMPE PECHO MAX MULTI SYMPTOMS — ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0290-2022·2021-12-29

    Rompe Pecho Cold & Flu Syrup Recalled for Microbial Contamination

    Efficient Laboratories is recalling Rompe Pecho CF Cold & Flu Advanced Formula syrup due to microbial contamination of the non-sterile product. The recall affects 10,833 bottles distributed nationwide.

    Product
    ROMPE PECHO — ROMPE PECHO (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0291-2022·2021-12-29

    Rompe Pecho Cough Syrup Recalled for Microbial Contamination

    Efficient Laboratories, Inc. is recalling Rompe Pecho DM cough syrup (6 fl oz bottles) due to microbial contamination of the non-sterile product. The recall affects 27,206 bottles distributed nationwide.

    Product
    ROMPE PECHO — ROMPE PECHO (DEXTROMETHORPHAN HBR, GUAIFENESIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0684-2017·2017-05-03

    Isomeric Pharmacy Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 1,951 vials of Triamcinolone Diacetate injection because production processes cannot assure sterility. The FDA has classified this as a Class II recall.

    Product
    Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
    Category
    Drug
    Distribution
    Distributed nationwide