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.

151–175 of 1691

HighFDA (Devices)·Z-2315-2023·2023-08-09
Custom Procedural Kits May Contain Non-Sterile Ultrasound Gel
Medline is recalling sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications. Approximately 6,939 kits were distributed between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY KIT, Model Number: ECVC7880; c. CVL INSERTION TRAY, Model Number: DYNDC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2320-2023·2023-08-09
Medical procedural kits recalled for potential sterile ultrasound gel defect
Medline is recalling 93,587 custom procedural kits worldwide because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2324-2023·2023-08-09
Medline Medical Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure
Medline Industries recalls 19,907 procedural kits because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Num
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0947-2023·2023-08-09
Rocuronium Injection Syringes Recalled for Sterility Assurance Deficiency
FDA recalls 77,554 rocuronium syringes nationwide due to lack of sterility assurance and inadequate validation data for sterilization processes. The drug was repackaged by Central Admixture Pharmacy Services, Inc.
Product
rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2306-2023·2023-08-09
Medline procedural kits recalled for potential sterility failure in ultrasound gel
Medline Industries is recalling 148,445 procedural kits containing Turkuaz Ultrasound Gel over potential sterility failure of the gel component, which could lead to infections if used in sterile procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2290-2023·2023-08-09
Medline Probe Cover Kits recalled for potential sterility specification failure
Medline is recalling 1,231,480 Probe Cover Kits distributed worldwide due to potential sterility specification failures in the ultrasound gel component.
Product
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0999-2023·2023-08-09
Neonatal TPN Starter Bags Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 84 bags of neonatal TPN starter bags due to lack of sterility assurance and missing validation data for decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0405-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1050-2023·2023-08-09
Fentanyl Injectable Solution Recalled for Unvalidated Sterilization Cycles
Central Admixture Pharmacy Services is recalling 848 bags of fentanyl injection nationwide due to lack of validated sterilization processes that assure product sterility. Multiple lots distributed to healthcare facilities are affected.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0972-2023·2023-08-09
FDA Recalls Oxytocin IV Bags for Sterility Assurance Issues
Central Admixture Pharmacy Services recalls 1,937 bags of oxytocin 10 units in Lactated Ringer's IV bags nationwide due to insufficient sterility assurance and missing validation data for decontamination cycles.
Product
oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6036-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1012-2023·2023-08-09
FDA recalls oxytocin-lactated ringer IV bags due to sterility concerns
Central Admixture Pharmacy Services recalls 33,073 bags of oxytocin 30 units with Lactated Ringer's 500 mL IV solution nationwide due to lack of validated sterilization. No illnesses reported.
Product
oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0981-2023·2023-08-09
Heparin intravenous bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 448 bags of heparin 7500 units in 0.9% sodium chloride IV solution due to lack of assurance of sterility. Validation data for decontamination cycles was not established.
Product
heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1010-2023·2023-08-09
FDA Recalls Neonatal TPN Bags for Inadequate Sterility Validation
Central Admixture Pharmacy Services is recalling 192 bags of Neonatal TPN Starter Bag distributed nationwide due to lack of sterilization validation. The company cannot assure the product's sterility.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0408-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0963-2023·2023-08-09
IV Phenylephrine bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services recalled 9,432 IV bags containing phenylephrine due to lack of assurance of sterility and insufficient validation data for decontamination cycles. The product was distributed nationwide.
Product
PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0973-2023·2023-08-09
FDA Recalls Oxytocin Injectable Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,821 bags of oxytocin IV bags nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.
Product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6042-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1016-2023·2023-08-09
FDA Recalls Cardioplegia Solution for Lack of Sterility Assurance
The FDA has recalled Central Admixture Pharmacy Services' Cardioplegia Solution 40 mEq K due to insufficient validation data for sterilization processes. The 80-bag lot may not meet sterility standards required for cardiac use.
Product
CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1058-2023·2023-08-09
HYDROmorphone Injection Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 2,077 syringes of HYDROmorphone injection (15 mg/30 mL) distributed nationwide due to lack of validation data for sanitization cycles. No adverse events have been reported.
Product
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1004-2023·2023-08-09
Neonatal IV Nutrition Bags Recalled Due to Sterility Assurance Failures
Central Admixture Pharmacy Services is recalling 224 neonatal TPN starter bags (250mL IV bags) distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1039-2023·2023-08-09
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot 36-254906) due to lack of assurance of sterility and missing validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0108-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2302-2023·2023-08-09
Medline surgical procedure kits recalled for potential sterility defect
Medline Industries is recalling 43,149 custom sterile and non-sterile procedural kits because the included Turkuaz ultrasound gel may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B, DYN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2023·2023-08-09
Custom procedural kits recalled for potential sterility failure in ultrasound gel
Medline recalled 134,514 custom surgical procedural kits due to potential sterility failure in the Turkuaz Ultrasound Gel component. The affected kits were distributed worldwide from April 1, 2020 through April 28, 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2293-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Failure
Medline has recalled approximately 29,277 procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall covers kits distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2318-2023·2023-08-09
Medical Procedural Kits Recalled Due to Ultrasound Gel Sterility Risk
Medline Industries is recalling 1,182 sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DELNOR VASCULAR BASIN PACK, Model Number: DYNJ82257; c. FLAP PACK, Model Number: DYNJ60224C;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0959-2023·2023-08-09
EPINEPHrine IV Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services, Inc. is recalling EPINEPHrine 8mg/250ml IV bags due to lack of sterility assurance and insufficient validation data for decontamination cycles. The recall affects 4,570 units distributed nationwide.
Product
EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2337-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Specification Failures
Medline Industries is recalling sterile procedural kits containing ultrasound gel that may not meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2321-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure
Medline is recalling 233,638 procedural kits containing Turkuaz ultrasound gel that may not meet sterility specifications. The potentially non-sterile gel could pose infection risks during medical procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d.
Category
Medical Device
Distribution
Distributed nationwide