Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 14,351–14,400 of 15,379
- Class II
Medical Device Recall · December 22, 2023
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplastyFailed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
- Class I
Medical Device Recall · December 22, 2023
Windstone Medical Packaging, Inc.
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEOSterility assurance for saline included in surgical kits cannot be guaranteed.
- Class I
Medical Device Recall · December 22, 2023
Windstone Medical Packaging, Inc.
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEOSterility assurance for saline included in surgical kits cannot be guaranteed.
- Class II
Medical Device Recall · December 21, 2023
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- Class II
Medical Device Recall · December 21, 2023
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- Class II
Medical Device Recall · December 21, 2023
Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626BMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
Medical Device Recall · December 21, 2023
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250RMedical devices distributed, prior to sterilization
- Class II
Drug Recall · December 21, 2023
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-311-10.MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Class II
Drug Recall · December 21, 2023
Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz, Distributed by AmerisourceBergen, 1 West First Ave, Conshochoken, PA 19428, NDCMICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Class II
Medical Device Recall · December 21, 2023
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175LMedical devices distributed, prior to sterilization
- Class II
Drug Recall · December 21, 2023
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-312-10.MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Class I
Drug Recall · December 21, 2023
8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-Presence of Particulate Matter; identified as glass
- Class II
Medical Device Recall · December 21, 2023
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
- Class II
Drug Recall · December 21, 2023
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Class II
Medical Device Recall · December 21, 2023
CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
- Class II
Medical Device Recall · December 21, 2023
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCTSpecific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
- Class II
Medical Device Recall · December 21, 2023
Phantom TTC Nail, 10.0 X 200mm, RightMedical devices distributed, prior to sterilization
- Class II
Medical Device Recall · December 21, 2023
Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
Medical Device Recall · December 21, 2023
Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
- Class II
Medical Device Recall · December 21, 2023
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- Class I
Drug Recall · December 21, 2023
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18Presence of particulate matter: glass
- Class II
Drug Recall · December 21, 2023
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98.MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622CMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class I
Drug Recall · December 21, 2023
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (cartoPresence of Particulate Matter; identified as glass
- Class II
Food Recall · December 21, 2023
Popcorn Pre-Pop in 8oz Polypropylene bag packaged 20 bags to a caseUndeclared Yellow #5
- Class II
Medical Device Recall · December 21, 2023
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.
- Class I
Drug Recall · December 21, 2023
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. MadeChemical Contamination: presence of benzene
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
- Class I
Drug Recall · December 21, 2023
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 04Presence of Particulate Matter; identified as glass
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
Medical Device Recall · December 21, 2023
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
- Class II
Medical Device Recall · December 21, 2023
Article No. NA6050411, Valiant PhD No. 1 EconoAffected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
MEDLINE INDUSTRIES, LP - Northfield
These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMIThere is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Lopez Valve¿ with ENFit, REF EN0056000BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Drug Recall · December 20, 2023
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Suction Connector with ENFit, REF EN0066000BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.