Hazard

Sterility Failure recalls

1,693 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,693
Critical: 12
Severe: 938
Most recent: 2026-09-30

Of the 1,693 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 938 (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.

176–200 of 1693

HighFDA (Devices)·Z-2305-2023·2023-08-09
Medline procedural kits with ultrasound gel may not meet sterility specifications
Medline Industries recalls 146,157 custom procedural kits distributed April 2020 to April 2023 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. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1061-2023·2023-08-09
Fentanyl Injectable Solution Recalled for Sterility Validation Failure
Central Admixture recalls 8,146 bags of fentanyl injection due to lack of sterilization cycle validation. This Class II recall affects patients nationwide who may receive contaminated IV medication.
Product
fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
Category
Drug
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2292-2023·2023-08-09
Medline procedural kits may contain non-sterile ultrasound gel
Medline is recalling 4,900 sterile procedural kits used for arterial line insertion because the 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. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number…
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 (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-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-0974-2023·2023-08-09
Heparin IV Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling heparin IV bags due to lack of sterility assurance and missing validation data for decontamination cycles. The recall affects 358 bags distributed nationwide.
Product
heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8000-1
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 (Devices)·Z-2307-2023·2023-08-09
Medline Procedural Kits with Turkuaz Ultrasound Gel Recalled for Sterility Concerns
Medline is recalling custom sterile procedural kits containing Turkuaz ultrasound gel due to potential sterility specification failures. 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. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B; b. BASIC BIOPSY TRAY, Model Number: DYNDH1534; c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485…
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 (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-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 (Devices)·Z-2309-2023·2023-08-09
Medline Procedural Kits with Ultrasound Gel Recalled for Sterility Risk
Medline is recalling 3,431 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. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model…
Category
Medical Device
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2297-2023·2023-08-09
Procedural kits containing Turkuaz ultrasound gel recalled for sterility failure
Medline Industries recalls approximately 97,677 procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The affected kits were distributed worldwide from April 1, 2020 to April 28, 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1037-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 356 bags of cardioplegia solution distributed nationwide. The recall is due to lack of assurance of sterility, as validation data for decontamination cycles is lacking.
Product
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
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 (Devices)·Z-2316-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel
Medline is recalling 6,733 custom procedural kits due to potential sterility failure in the Turkuaz ultrasound gel component. The gel may not meet required sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS…
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 (Devices)·Z-2314-2023·2023-08-09
Medline procedural kits with potentially non-sterile ultrasound gel recalled
Medline Industries is recalling 80 custom procedural kits containing ultrasound gel that may not meet sterility specifications. 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. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1076-2023·2023-08-09
Rocuronium Syringes Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling rocuronium syringes due to lack of validation data for sanitization cycles, which cannot assure sterility. The recall affects 10,065 syringes distributed nationwide.
Product
rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0961-2023·2023-08-09
Phenylepherine IV bags recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling over 8,300 phenylepherine IV bags nationwide because sterilization procedures were not adequately validated. Sterility cannot be assured for the affected units.
Product
PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2291-2023·2023-08-09
Medline Anesthesia Procedural Kits Recalled for Potential Sterility Failure
Medline Industries recalls 1,130 anesthesia procedural kits over concerns that the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide including the US from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANESTHESIA CVL KIT-LF, Model Number: DYNJ52283C; b. ANESTHESIA OH TOTE, Model Number: DYNJ61476;
Category
Medical Device
Distribution
Distributed nationwide