The Recall Desk

Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,438
Critical
25
Severe
993
Most recent
2026-10-14

Of the 3,438 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 993 (29%) 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 infection risk 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.

601–625 of 3438

  • HighFDA (Devices)·Z-2131-2023·2023-07-19

    Medline PVP solution mislabeled as sterile when non-sterile

    Medline Industries is recalling batches of non-sterile PVP solution that were incorrectly labeled as sterile, creating risk of inadvertent use in sterile medical settings.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2023·2023-07-19

    Medline Non-Sterile PVP Solution Mislabeled as Sterile

    Medline Industries is recalling 128 units of non-sterile PVP solution incorrectly labeled as sterile. Using a non-sterile product in sterile contexts could create infection risk.

    Product
    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2023·2023-07-12

    SurgiMend MP Collagen Matrix Recalled for Endotoxin Testing Issues

    TEI Biosciences recalled approximately 3,992 units of SurgiMend MP surgical implants nationwide due to issues with endotoxin testing procedures that may have resulted in unreliable test results.

    Product
    SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2023·2023-07-12

    Custom Medical Procedure Packs Recalled for Compromised Package Seals

    DeRoyal Industries is recalling 306 custom medical procedure packs because the outer package seals could be open or compromised, affecting the sterility of the contents. Affected packs were distributed nationwide.

    Product
    Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2023·2023-06-28

    Medline TheraHoney Gel Wound Dressing Recalled for Sterilization Failure

    Medline is recalling 851,328 units of TheraHoney Gel wound dressing due to inadequate sterilization. The manufacturer failed to augment the sterilization dose after an audit failure, violating ISO 11137 standards.

    Product
    MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2023·2023-06-07

    Maquet QUADROX-iR Cardiopulmonary Bypass Device Recalled for Packaging Damage

    Maquet Medical Systems USA is recalling QUADROX-iR cardiopulmonary bypass devices due to damaged packaging that may compromise sterility. This could result in infection, sepsis, or ischemia.

    Product
    QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2023·2023-06-07

    Maquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier

    Maquet Medical Systems is recalling QUADROX-i Adult Oxygenators due to potential packaging damage that may compromise sterile barriers, risking infection during cardiopulmonary bypass surgery.

    Product
    BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0698-2023·2023-05-31

    FDA Recalls Neonatal Parenteral Nutrition Bags for Sterility Concerns

    Central Admixture Pharmacy Services recalled 328 neonatal parenteral nutrition bags nationwide due to FDA concerns about product sterility after an inspection.

    Product
    Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0719-2023·2023-05-31

    Vancomycin Dextrose Injectable Recalled Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling 13,772 bags of vancomycin-dextrose injectable distributed nationwide after an FDA inspection questioned its sterility assurance. No illnesses have been reported.

    Product
    vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0754-2023·2023-05-31

    FDA Recalls HyperLyte CR Injection for Lack of Sterility Assurance

    The FDA recalled HyperLyte CR Injection because the manufacturer could not assure the product met sterility requirements. The recall affects 554 bags distributed nationwide.

    Product
    HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0731-2023·2023-05-31

    Heparin Injection Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling heparin injectable solutions nationwide due to sterility concerns identified during an FDA inspection. Over 11,000 bags of the product are affected.

    Product
    heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0708-2023·2023-05-31

    FDA Recalls Oxytocin Injection Bags Over Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 3,865 bags of oxytocin injection across the USA due to lack of sterility assurance identified during an FDA inspection. Sterile injectables must meet strict standards to prevent infection risk.

    Product
    oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0674-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.

    Product
    Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0752-2023·2023-05-31

    Potassium Acetate Injection Recalled for Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling Potassium Acetate Injection after an FDA inspection raised concerns about sterility assurance. The recall affects 3,326 bags nationwide.

    Product
    Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0648-2023·2023-05-31

    Microplegia injectable recalled for lack of sterility assurance

    Central Admixture Pharmacy Services recalls Microplegia injectable solution due to FDA concerns about sterility assurance. The product was distributed nationwide across the United States.

    Product
    Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0001-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0715-2023·2023-05-31

    Phenylephrine Injectable Solution Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 6,407 bags of phenylephrine injectable solution nationwide because FDA inspection questioned the sterility assurance of the product.

    Product
    PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6058-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0734-2023·2023-05-31

    NORepinephrine Injectable Recalled Nationwide for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 6,341 bags of NORepinephrine nationwide due to FDA concerns about sterility assurance. An FDA inspection found the manufacturer could not adequately ensure the product's sterility.

    Product
    NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7036-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0751-2023·2023-05-31

    Injection Solution Recalled Due to Sterility Assurance Concerns

    Nationwide recall of Sodium Phosphates Injection due to lack of sterility assurance after FDA inspection. Patients receiving this medication should consult their healthcare provider.

    Product
    Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0700-2023·2023-05-31

    Neonatal Parenteral Nutrition Bags Recalled Due to Sterility Concerns

    Central Admixture Pharmacy Services recalls 175 bags of neonatal TPN solution nationwide due to FDA inspection findings that questioned the sterility assurance of the product.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0432-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0687-2023·2023-05-31

    Neonatal Parenteral Nutrition Starter Bags Recalled for Sterility Concerns

    Central Admixture Pharmacy Services is recalling 258 bags of Neonatal TPN Starter Bag due to lack of assurance of sterility following an FDA inspection. The product is distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0413-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0747-2023·2023-05-31

    Injectable Vasopressin Products Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalled 1,858 bags of injectable vasopressin nationwide due to FDA concerns about sterility assurance. An FDA inspection questioned whether the products meet required sterility standards.

    Product
    vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0764-2023·2023-05-31

    Nafcillin for Injection Recalled Nationwide for Lack of Sterility Assurance

    Sagent Pharmaceuticals has recalled Nafcillin for Injection due to lack of sterility assurance. The recall affects approximately 370,200 bottles distributed nationwide.

    Product
    Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0671-2023·2023-05-31

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls Cardioplegia Solution (Maintenance 4:1 in Ringer's) due to lack of sterility assurance confirmed by FDA inspection. The product is used during cardiac surgery and distributed nationwide.

    Product
    Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0710-2023·2023-05-31

    Oxytocin Injectable Solution Recalled for Sterility Assurance Questions

    Central Admixture Pharmacy Services is recalling oxytocin injectable solution after FDA inspection questioned sterility. Over 104,000 bags distributed nationwide are affected.

    Product
    oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6044-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0718-2023·2023-05-31

    Vancomycin Injectable Solution Recalled Due to Sterility Assurance Concerns Nationwide

    Central Admixture Pharmacy Services is recalling 3,075 bags of vancomycin injectable solution nationwide due to lack of assurance of sterility following an FDA inspection.

    Product
    vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1.
    Category
    Drug
    Distribution
    Distributed nationwide