Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 10,951–11,000 of 15,364
- Class II
Medical Device Recall · July 24, 2024
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following mePotential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
- Class II
Medical Device Recall · July 24, 2024
Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medicalPotential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
- Class II
Medical Device Recall · July 24, 2024
Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medicalPotential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
- Class II
Medical Device Recall · July 24, 2024
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, ManPatient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
- Class II
Medical Device Recall · July 24, 2024
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
- Class I
Drug Recall · July 24, 2024
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.Presence of Particulate Matter
- Class II
Medical Device Recall · July 24, 2024
Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following mPotential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
- Class II
Medical Device Recall · July 24, 2024
McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)Affected syringes lack FDA clearance.
- Class I
Medical Device Recall · July 24, 2024
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring SystemUsers of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.
- Class II
Medical Device Recall · July 24, 2024
Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following mediPotential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
- Class II
Medical Device Recall · July 24, 2024
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 4The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
- Class II
Medical Device Recall · July 24, 2024
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical apPotential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
- Class II
Medical Device Recall · July 24, 2024
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following mePotential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
- Class II
Medical Device Recall · July 24, 2024
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach TubeThe firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
- Class II
Food Recall · July 24, 2024
FULL CIRCLE market COCONUTMILK CHOCOLATE ALMOND CRUNCH NON0DAIRY FROZEN DESSERT 16 FLOZ (1PT) 473 mL UPC 0 36800 46964 8 DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007Undeclared cashews. The firm was notified by a customer that the top label and the carton labels do not match. The carton label states, "coconut milk" while the top label states, "cashew milk". The product actually contains the cashew milk product.
- Class II
Medical Device Recall · July 24, 2024
Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical aPotential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
- Class II
Medical Device Recall · July 24, 2024
Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following mePotential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
- Class II
Medical Device Recall · July 24, 2024
Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical apPotential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
- Class II
Medical Device Recall · July 24, 2024
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
- Class II
Medical Device Recall · July 23, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 21103Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.
- Class II
Medical Device Recall · July 23, 2024
Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · July 23, 2024
VariSoft Infusion Set, Single Use.Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
- Class II
Medical Device Recall · July 23, 2024
Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Drug Recall · July 23, 2024
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. ManufactDefective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- Class II
Medical Device Recall · July 23, 2024
Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · July 23, 2024
Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · July 23, 2024
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · July 23, 2024
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · July 23, 2024
Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · July 23, 2024
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- Class II
Medical Device Recall · July 22, 2024
SlideView VS200 slide viewer,A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This short circuit was caused by a badly positioned cable that made contact with the housing/frame and caused a short circuit and destroyed the fuse in the laser. This caused the shutter to remain in its most recent state; either in an open or closed position. Once the fuse was destroyed the shutter could not be operated.
- Class II
Medical Device Recall · July 22, 2024
Mindray DS USA, Inc. dba Mindray North America
Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
- Class II
Medical Device Recall · July 22, 2024
Mindray DS USA, Inc. dba Mindray North America
Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part NumberV90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
- Class III
Food Recall · July 22, 2024
Frozen Food Processors - Jalapeno Cornbread Muffins packaged in 2oz corrugated cardboard boxes lined with food grade plastic bags. Keep frozen at 0F or lower until time of use. 96 individual muffins pManufacturing without State License and in unsanitary conditions.
- Class II
Medical Device Recall · July 22, 2024
Mindray DS USA, Inc. dba Mindray North America
Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part NumberV90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
- Class II
Medical Device Recall · July 22, 2024
Mindray DS USA, Inc. dba Mindray North America
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part NumberV90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
- Class III
Food Recall · July 22, 2024
Frozen Food Processors - Regular Cornbread Muffins packaged in 2oz corrugated cardboard boxes lined with food grade plastic bags. Keep frozen at 0F or lower until time of use. 96 individual muffins peManufacturing without State License and in unsanitary conditions.
- Class II
Food Recall · July 20, 2024
Izzio Everything Sourdough. Single 24oz loaf packaged into plastic bag. 12 loaves per case.Potential foreign material - plastic
- Class II
Food Recall · July 20, 2024
Izzio Everything Roll packaged in 12oz plastic bag, 6 rolls per bag - 16 bags per case.Potential foreign material - plastic
- Class II
Food Recall · July 20, 2024
Aldi Mixed Sourdough loaf. A single 24oz loaf packaged into plastic bag, 12 loaves per case.Potential foreign material - plastic
- Class I
Food Recall · July 19, 2024
Green Peppers packaged as whole 10lb carton, whole 20lb carton, whole 5lb cartonPotential contamination with Listeria monocyotgenes
- Class II
Medical Device Recall · July 19, 2024
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare setSoftware anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
- Class I
Food Recall · July 19, 2024
Pico de Gallo Classic Hot - 14 oz 639123880116 Pico de Gallo Classic Medium - 14 oz 639123880093 Pico de Gallo Classic Mild - 14 oz 639123880109 Plastic Clam-Shell ContainerListeria monocytogenes
- Class I
Food Recall · July 19, 2024
Guacamole & Pico de Gallo Combo $7.99 - 16 oz 639123880574 Guacamole Chunky Medium - 14 oz 639123880161 Guacamole Chunky Mild - 14 oz 639123880154 Guacamole Blender Mild $5.99 - 12 oz 639Listeria monocytogenes
- Class II
Food Recall · July 19, 2024
Cheese Danish in a clear plastic bag with a white paper label attached to the top of the plastic bag.Finished product label stated cheese in the product name but did not declare milk in the ingredients or allergen statement.
- Class I
Food Recall · July 19, 2024
GBC Food Services, LLC dba Yummi Sushi
Supreme Guacamole Chunky Mild 8-50053-68588 17 OZ Supreme Guacamole Chunky Medium 8-50053-68589 17 OZ Supreme Pico/Guacamole 8-50054-89443 16 OZ Supreme Pico/Guacamolepossible contamination with Listeria Monocytogenes.
- Class II
Food Recall · July 19, 2024
Pita Jungle Cilantro Jalapeno Hummus & Pita Chips packaged as individual "snack pack" in 9.2oz plastic clamshell container.Finished product label does not declare sesame which is an ingredient of hummus (tahini).
- Class I
Food Recall · July 19, 2024
Chopped Cilantro with White Onion - 5oz Plastic Clam-Shell ContainerListeria monocytogenes
- Class I
Food Recall · July 19, 2024
Diced Pepper Tri-Blend - 8 oz 639123880024 Diced Pepper w/ White Onion - 7 oz 639123880048 Fajita Mix, Hot $5.00 - 11 oz 639123880406 Fajita Mix, Mild $5.00 - 11 oz 639123880390 DicedListeria monocytogenes