Hazard Type
Sterility Issue Recalls
10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.
10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls
Every Sterility Issue Recall
Sorted by most recent. Click any recall for full details and safety information.
10,814 recalls
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs7 affectedOct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs168 affectedOct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th A...
Drugs2 affectedOct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Injectable Drugs50 affectedOct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs67 affectedOct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Drugs389 affectedOct 7, 2022
High RiskFDA
Pharmacy Plus, Inc. Dba Vital Care Compounder
MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, M...
Injectable Drugs185 affectedOct 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
Medical Devices50 affectedSep 30, 2022
High RiskFDA
Boston Scientific Corporation
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Medical Implants7 affectedSep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
Medical Devices60 affectedSep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
Medical Devices50 affectedSep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
Medical Devices240 affectedSep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
Surgical Devices800 affectedSep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
Surgical Devices28 affectedSep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
Surgical Devices96 affectedSep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
Surgical Devices160 affectedSep 30, 2022
High RiskFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Medical Implants142 affectedSep 30, 2022
High RiskFDA
Cipla
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch...
Drugs9,041 affectedSep 29, 2022
High RiskFDA
Teleflex Llc
Pilling Wecksorb Cylindrical Sponges
Medical Devices1,000 affectedSep 28, 2022
High RiskFDA
Synthes (usa) Products Llc
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Medical Implants96 affectedSep 27, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
Medical Devices318 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
Medical Devices16 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST
Medical Devices451 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
Medical Devices265 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST
Medical Devices1,143 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
Medical Devices483 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
Medical Devices493 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
Medical Devices334 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST
Medical Devices319 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
Medical Devices510 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST
Medical Devices259 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST
Medical Devices537 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST
Medical Devices1,132 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST
Medical Devices308 affectedSep 26, 2022
High RiskFDA
Carefusion 2200 Inc
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST
Medical Devices50 affectedSep 26, 2022
High RiskFDA
Eden's Answers Inc
Sprigs - Honey Herbal Syrup: Herbal Dietary Supplement 8oz glass amber bottles with black dropper, 12 units per case
Supplements73 affectedSep 22, 2022
High RiskFDA
Eden's Answers Inc
Sprigs - Lil Ones Sleepy Time: Herbal Dietary Supplement 2oz glass amber bottles with black dropper, 12 units per case
Supplements828 affectedSep 22, 2022
High RiskFDA
Eden's Answers Inc
Sprigs - Dental Health: Herbal Dietary Supplement 8oz glass amber bottles with black dropper, 12 units per case
Supplements2,594 affectedSep 22, 2022
High RiskFDA
Teleflex Llc
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Surgical Devices7,200 affectedSep 20, 2022
High RiskFDA
Cipla
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile ...
Drugs641,160 affectedSep 15, 2022
High RiskFDA
Avanos Medical, Inc.
Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRO...
Medical Devices1,378 affectedSep 14, 2022
High RiskFDA
Medline Industries, Lp - Northfield
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Medical Devices18 affectedSep 7, 2022
High RiskFDA
Superior Glove Works, Ltd.
Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are ...
Topical Drugs7,296 affectedSep 1, 2022
High RiskFDA
Akorn, Inc.
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Drugs82,689 affectedAug 31, 2022
High RiskFDA
Akorn, Inc.
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478...
Topical Drugs48,636 affectedAug 31, 2022
CriticalFDA
Teleflex Llc
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
Medical Devices164 affectedAug 29, 2022
CriticalFDA
Teleflex Llc
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medica...
Medical Devices355 affectedAug 29, 2022
CriticalFDA
Teleflex Llc
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in bre...
Medical Devices60,500 affectedAug 29, 2022