Recalls in Mississippi (page 26)
3949 recalls.
- Lidocaine Wound Gel recall (Water-Jel Technologies, LLC)
DrugClass IIIReported May 6, 2026 · Failed PH Specifications - fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - Ketamine Hydrochloride Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - Phenylephrine Hydrochloride Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - Similasan recall (Thea Pharma, Inc.)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. - iVIZIA recall (Thea Pharma, Inc.)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. - Optase Dry Eye Intense Drops recall (SCOPE HEALTH)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility - Levocarnitine Injection recall (American Regent, Inc.)
DrugClass IIIReported May 6, 2026 · Labeling: Missing Label - GenTeal Tears recall (Alcon Research LLC)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. - Systane recall (Alcon Research LLC)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. - Medline and Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline or Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline and Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - epoc BGEM BUN Test Card recall (Siemens Healthcare Diagnostics Inc)
Medical deviceClass IIReported May 6, 2026 · Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial... - Philips Bridge Prep Kit REF: K12-09098C Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported May 6, 2026 · catheter may experience resistance when being advanced over the guidewire - Philips Bridge Prep Kit REF: K12-09098C Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported May 6, 2026 · catheter may experience resistance when being advanced over the guidewire - Philips Bridge Prep Kit REF: K12-09098B Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported May 6, 2026 · catheter may experience resistance when being advanced over the guidewire - i-STAT G3+ cartridge recall (Abbott Point Of Care Inc.)
Medical deviceClass IIReported May 6, 2026 · Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26)... - i-STAT EG6+ cartridge recall (Abbott Point Of Care Inc.)
Medical deviceClass IIReported May 6, 2026 · Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26)... - i-STAT EG7+ cartridge recall (Abbott Point Of Care Inc.)
Medical deviceClass IIReported May 6, 2026 · Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26)... - Heraeus recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIIReported May 6, 2026 · Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its... - Heraeus recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIIReported May 6, 2026 · Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its... - iLet Bionic Pancreas recall (Beta Bionics, Inc.)
Medical deviceClass IIReported May 6, 2026 · insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch... - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use recall (Becton Dickinson & Co.)
Medical deviceClass IIReported May 6, 2026 · BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce... - BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use recall (Becton Dickinson & Co.)
Medical deviceClass IIReported May 6, 2026 · BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce... - Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported May 6, 2026 · Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the... - Philips Upgrade to MR 7700 with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips SmartPath to Ingenia Elition X with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips SmartPath to dStream for XR and 3.0T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips SmartPath to dStream for 3.0T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips SmartPath to dStream for 1.5T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips MR 7700 with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia Elition X with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia Elition S with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia Ambition X with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia Ambition S with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia 3.0T CX with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia 3.0T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia 1.5T CX with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia 1.5T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Evolution upgrade 3.0T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Evolution Upgrade 1.5T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Achieva 3.0T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Achieva 1.5T Initial system with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Achieva 1.5T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Brand Name: Genius" Review Station Product Name: Genius" Review Station Display recall (Hologic, Inc)
Medical deviceClass IIReported May 6, 2026 · It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the... - VACUUM BAG SU LARGE recall (Milestone S.R.L.)
Medical deviceClass IIReported May 6, 2026 · There is a possibility of reagent leakage from the specimen container. - Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style recall (Healthmark Industries Co., Inc.)
Medical deviceClass IIReported May 6, 2026 · Product does not have FDA clearance. - American Honda Motor Recalls Off-Road Motorcycles Due to Risk of Serious Injury or Death Due to Crash Hazard
Consumer productReported May 1, 2026 · The handlebar's clamp can unexpectedly cause the handlebar to rotate, posing a risk of serious injury or death due to a crash hazard. - Build-A-Bear Workshop Recalls Heartwarming Hugs Bears Due to Risk of Serious Injury or Death from Choking Hazard to Children
Consumer productReported May 1, 2026 · The zipper slider on the side pouch can detach, posing a risk of serious injury or death from choking hazard to children. - CBC Group Recalls Stephan Baby Boo Bunnie and Friends Children's Toys Due to Risk of Serious Injury from Choking and Laceration Hazards
Consumer productReported May 1, 2026 · The toys' plastic cube can break into small parts or sharp edges, posing a risk of serious injury from choking and laceration hazards. - Bayer Recalls 6 mL Size Afrin Original Nasal Spray Bottles Due to Risk of Serious Injury or Illness from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging
Consumer productReported May 1, 2026 · The 6 mL nasal sprays contain an imidazoline, which must be in child-resistant packaging or meet the labeling requirements for non-complying packaging, as... - Qumeney Bicycle Light Sets Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by Smfanlus
Consumer productReported May 1, 2026 · The recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries... - Acer America Corporation Recalls Two-Wheeled Folding Electric Due to Risk of Injury from Fall Hazard
Consumer productReported May 1, 2026 · A loose screw can cause the front tube to fold down unexpectedly, posing a risk of injury from a fall hazard. - Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Imported by DGIVOVO US
Consumer productReported May 1, 2026 · The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution... - Earthtec Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Tonyidea
Consumer productReported May 1, 2026 · The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and... - Residential Elevators Recalls Elevator StrikeLock Hoistway Door Locking Device Due to Risk of Serious Injury or Death from Fall and Injury Hazards
Consumer productReported May 1, 2026 · The elevator's StrikeLock hoistway door locking device can allow the elevator cab to move with a landing door open, posing a risk of serious injury or death... - Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Imported by Hepo Care Medical Equipment Online
Consumer productReported May 1, 2026 · The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed... - 5-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units; Imported by UHOMEPRO
Consumer productReported May 1, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - Malker Bicycle Light Sets Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by MalkerDirect
Consumer productReported May 1, 2026 · The recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries... - Segmart 4-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violate Mandatory Standard for Clothing Storage Units; Sold on Walmart.com by SOFT
Consumer productReported May 1, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - Alliance Chemical Recalls 1-K Kerosene Heater Fluid Containers Due to Risk of Serious Injury or Death from Flash Fire, Burn and Child Poisoning; Violates Mandatory Standards for Portable Fuel Containers
Consumer productReported May 1, 2026 · The pre-filled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under... - Thermos Recalls 8.2 Million Stainless King Food Jars and Bottles Due to Serious Impact Injury and Laceration Hazards
Consumer productReported May 1, 2026 · If perishable food or beverages are stored in the container for an extended period of time, the stopper can forcefully eject when opened, which can result in... - Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall (Diversatek Healthcare)
Medical deviceClass IIReported April 29, 2026 · The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each... - Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall (Diversatek Healthcare)
Medical deviceClass IIReported April 29, 2026 · The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each... - Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall (Diversatek Healthcare)
Medical deviceClass IIReported April 29, 2026 · The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each... - Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator recall (Diversatek Healthcare)
Medical deviceClass IIReported April 29, 2026 · The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each... - Claravis recall (Teva Pharmaceuticals USA, Inc)
DrugClass IIReported April 29, 2026 · Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin - LACTATED RINGER'S IRRIGATION recall (B BRAUN MEDICAL INC)
DrugClass IIReported April 29, 2026 · Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. - 0.9 % SODIUM CHLORIDE IRRIGATION recall (B BRAUN MEDICAL INC)
DrugClass IIReported April 29, 2026 · Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. - DEXTROSE INJECTION USP recall (B BRAUN MEDICAL INC)
DrugClass IIReported April 29, 2026 · Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. - Sterile Water for Injection USP recall (B BRAUN MEDICAL INC)
DrugClass IIReported April 29, 2026 · Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. - Omega-3-Acid recall (The Harvard Drug Group LLC)
DrugClass IIReported April 29, 2026 · Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. - Premier recall (Premier Dental Products Co)
DrugClass IIIReported April 29, 2026 · Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14).... - FRESHKOTE LUBRICANT EYEDROPS recall (Harrow Eye LLC)
DrugClass IIReported April 29, 2026 · Lack of Assurance of Sterility - Furosemide Tablets recall (Leading Pharma, LLC)
DrugClass IIReported April 29, 2026 · CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. - Pantoprazole Sodium recall (Hetero Labs Limited (Unit V))
DrugClass IIReported April 29, 2026 · Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." - LSL Healthcare Wound Closure Tray recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - LSL Healthcare recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - LSL Healthcare recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - LSL Healthcare recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - LSL Healthcare recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. - LSL Healthcare recall (LSL Healthcare Inc.)
Medical deviceClass IIReported April 29, 2026 · Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.