Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,691
Critical: 12
Severe: 931
Most recent: 2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 sterility failure 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.

1076–1100 of 1691

ModerateFDA (Devices)·Z-2743-2016·2016-09-14
Integra Recalls Achillon Suture System Due to Sterility Concerns
Integra LifeSciences is recalling the Achillon Suture System because internal studies suggest the secondary package seal may not maintain intended sterility.
Product
Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2462-2016·2016-08-24
Biomet 3i Recalls Drill Stop Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling Drill Stop Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
Product
Drill Stop Dental implants
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2281-2016·2016-08-03
Stryker Trident Constrained Liner Inserter Impactor Tip Recall
Stryker is recalling Trident Constrained Liner Inserter Impactor Tips because they do not meet required sterility assurance levels when steam sterilized.
Product
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2213-2016·2016-07-27
AMD-RITMED Conforming Stretch Gauze Bandages Recalled for Sterility Failure
AMD-RITMED is recalling specific lots of sterile conforming stretch gauze bandages because FDA testing showed they did not meet sterility requirements.
Product
AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawa
Category
Medical Device
Distribution
3 states
SevereFDA (Drugs)·D-1184-2016·2016-07-20
Medaus Recalls Folic Acid Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Folic Acid 10mg/mL vials due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.
Product
FOLIC ACID 10MG/ML IN NACL (PF), 1ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1330-2016·2016-07-20
Pharmakon Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 800 syringes of Ephedrine Sulfate 5 mg/ml due to a lack of assurance of sterility.
Product
Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1169-2016·2016-07-20
Medaus Recalls B-Complex Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling B-Complex (Lieberman) in NaCl 0.9% (PF) 2 mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Product
B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML, 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1285-2016·2016-07-20
Pharmakon Recalls Fentanyl Citrate Cadd Cassettes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 10mcg/mL cadd cassettes due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.
Product
Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1310-2016·2016-07-20
Pharmakon Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 100 units of compounded Fentanyl and Bupivacaine syringes due to a lack of assurance of sterility.
Product
Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1338-2016·2016-07-20
Pharmakon Recalls Midazolam HCI Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 2,000 units of compounded Midazolam HCI syringes due to a lack of assurance of sterility.
Product
Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1261-2016·2016-07-20
Pharmakon Recalls Ceftriaxone Injections Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 1,575 units of compounded Ceftriaxone 1GM injections due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1305-2016·2016-07-20
Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 560 vials of Hydromorphone HCl 0.4mg/mL in 30 mL syringes due to a lack of assurance of sterility.
Product
HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1222-2016·2016-07-20
Medaus Recalls B-Complex Premix Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of M.I.C B-Complex Premix vials because the company cannot ensure the product is sterile.
Product
M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1325-2016·2016-07-20
Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 90 units of Hydromorphone HCI syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1279-2016·2016-07-20
Pharmakon Recalls Cefazolin Sodium Chloride Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 100 mL 0.9% Sodium Chloride bags because the company cannot guarantee the products are sterile.
Product
Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0216-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1188-2016·2016-07-20
Medaus Recalls Hyaluronidase Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Hyaluronidase 500U/ML vials because the company cannot assure the sterility of the product. The recall affects lots distributed in the U.S., Japan, and New Zealand.
Product
HYALURONIDASE 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1252-2016·2016-07-20
Medaus Recalls Arginine Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling specific lots of Arginine 100mg/mL vials because the company cannot assure the product is sterile.
Product
ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1220-2016·2016-07-20
Medaus Recalls M.I.C. 25/50/50 Vials Due to Sterility Concerns
Medaus, Inc. is recalling M.I.C. 25/50/50 (PF) vials because the company cannot ensure the product is sterile. The recall covers multiple lots distributed in the U.S., Japan, and New Zealand.
Product
M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1219-2016·2016-07-20
Medaus Recalls Methyl B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Methyl B12 10mg/mL vials because the company cannot guarantee the product is sterile.
Product
METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1196-2016·2016-07-20
Medaus Recalls L-Carnitine Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of L-Carnitine 250mg/mL vials because the company cannot guarantee the product is sterile.
Product
L-CARNITINE 250MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1228-2016·2016-07-20
Medaus Recalls Sodium Ascorbate Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Sodium Ascorbate 500mg/mL vials because the company cannot ensure the product is sterile.
Product
NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1166-2016·2016-07-13
Vital Care Compounder Recalls Testosterone Cypionate Due to Sterility Concerns
Vital Care Compounder is recalling 13 units of Testosterone Cypionate 200mg/ml because aluminum crimps may not fully seal the vials, compromising sterility.
Product
TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-1054-2016·2016-07-06
Vital Care Compounder Recalls Methylcobalamin Vials Due to Sterility Concerns
Vital Care Compounder is recalling 39 vials of Methylcobalamin 5,000 mcg/ml because aluminum crimps may not fully seal the rubber stoppers, compromising sterility.
Product
Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-2054-2016·2016-07-06
Nephron Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns
Nephron Pharmaceuticals is recalling 13,692 cartons of Sodium Chloride Inhalation Solution due to a failure in the internal dye ingress test, which raises concerns about the sterility of the vials.
Product
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For res
Category
Medical Device
Distribution
36 states
SevereFDA (Drugs)·D-1025-2016·2016-06-15
Well Care Compounding Pharmacy Recalls QUAD-MIX #3 Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling QUAD-MIX #3 vials because FDA inspections found violations that may affect product sterility.
Product
QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Category
Drug
Distribution
1 state