Safety Recalls
RSS ↗15,362 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 8,601–8,650 of 15,362
- Class II
Medical Device Recall · December 23, 2024
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- Class II
Drug Recall · December 23, 2024
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6CGMP Deviations; product intended for quarantine was inadvertently distributed
- Class II
Medical Device Recall · December 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
- Class II
Drug Recall · December 23, 2024
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- Class II
Medical Device Recall · December 23, 2024
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
- Class I
Drug Recall · December 23, 2024
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- Class II
Medical Device Recall · December 23, 2024
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
- Class I
Medical Device Recall · December 23, 2024
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLEDue to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
- Class I
Drug Recall · December 23, 2024
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- Class II
Drug Recall · December 23, 2024
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- Class II
Medical Device Recall · December 23, 2024
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated forSnap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Food Recall · December 20, 2024
Rajbhog Sweets Jelebi Yellow, 9.5 oz packages and sold by weight from bulk trays.Undeclared milk
- Class II
Medical Device Recall · December 20, 2024
PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic anSutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class II
Medical Device Recall · December 20, 2024
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class I
Medical Device Recall · December 20, 2024
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class II
Drug Recall · December 20, 2024
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, PitFailed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
- Class II
Medical Device Recall · December 20, 2024
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft maDue to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
- Class I
Medical Device Recall · December 20, 2024
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
- Class I
Medical Device Recall · December 20, 2024
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
- Class II
Food Recall · December 20, 2024
Buttered Vegetables KEEP FROZEN NET WT 10.5 OZ (300g) INGREDIENTS: CARROTS, PEAS, CALIFLOWER, CORN, BUTTER, SUGAR, SALT, CORN STARCH, PARSLEY MAY CONTAIN WHEAT. DISTRIBUTED BY LIDL USA, LLC. 3500 S. CUndeclared Milk. During an FDA investigation the manufacturer was notified that the label does not list the allergen milk in the ingredient statement.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class I
Drug Recall · December 20, 2024
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
- Class II
Medical Device Recall · December 20, 2024
Baxter Solution Set with Duo-Vent Spike, REF 2R8404Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class I
Medical Device Recall · December 20, 2024
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class I
Medical Device Recall · December 20, 2024
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002APThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class I
Medical Device Recall · December 20, 2024
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002APThere is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthaSutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
- Class II
Food Recall · December 20, 2024
Rajbhog Sweets Jelebi Jaggery, 9.5 oz packages and sold by weight from bulk trays.Undeclared milk
- Class II
Food Recall · December 20, 2024
Rajbhog Sweets Jelebi Orange, 9.5 oz packages and sold by weight from bulk trays.Undeclared milk
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in USSutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 20, 2024
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
- Class II
Medical Device Recall · December 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · December 19, 2024
8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Class II
Medical Device Recall · December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Drug Recall · December 19, 2024
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.