Safety Recalls

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15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 10,601–10,650 of 15,364

Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
PACEMAKER PACK, SLCV01J; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Neuro Vascular, ANKV91A; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · August 7, 2024
Howmedica Osteonics Corp.
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
ENT, COEN27N; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Vehicle Recall · August 7, 2024
Nova Bus (US) Inc.
2023 NOVA BUS LFS
Damaged wiper blades can reduce visibility in certain weather conditions, increasing the risk of a crash.
Unclassified
Medical Device Recall · August 7, 2024
Fisher & Paykel Healthcare, Ltd.
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spont
Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.
Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Day Surgery General Pack, FHGE18T; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · August 7, 2024
B Braun Medical Inc
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.
Class I
Medical Device Recall · August 7, 2024
Cook Biotech, Inc.
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
Products expire prior to the expiration date printed on the product labeling
Class II
Medical Device Recall · August 7, 2024
Cook Biotech, Inc.
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
Products expire prior to the expiration date printed on the product labeling
Class II
Drug Recall · August 7, 2024
Taro Pharmaceuticals U.S.A., Inc.
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawth
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class III
Vehicle Recall · August 7, 2024
Nova Bus (US) Inc.
2023 NOVA BUS LFS
A bus that stops suddenly without activating brake lights increases the risk of a crash.
Unclassified
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Pacemaker, COPM11B; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · August 7, 2024
Cook Biotech, Inc.
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
Products expire prior to the expiration date printed on the product labeling
Class II
Medical Device Recall · August 7, 2024
Cook Biotech, Inc.
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373
Products expire prior to the expiration date printed on the product labeling
Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Cath Lab Pack, CECL02P; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · August 7, 2024
BioFire Diagnostics, LLC
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.
Class II
Medical Device Recall · August 7, 2024
Cook Biotech, Inc.
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
Products expire prior to the expiration date printed on the product labeling
Class II
Medical Device Recall · August 7, 2024
American Contract Systems, Inc.
Cysto, FTCY03L; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Class II
Medical Device Recall · August 7, 2024
Cook Biotech, Inc.
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
Products expire prior to the expiration date printed on the product labeling
Class II
Medical Device Recall · August 7, 2024
Cook Biotech, Inc.
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667
Products expire prior to the expiration date printed on the product labeling
Class II
Medical Device Recall · August 6, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel.
Class II
Drug Recall · August 6, 2024
Dr. Reddy's Laboratories, Inc.
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tabl
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II
Medical Device Recall · August 6, 2024
Cypress Medical Products LLC
General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.
Class II
Drug Recall · August 6, 2024
Dr. Reddy's Laboratories, Inc.
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablet
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II
Drug Recall · August 6, 2024
Dr. Reddy's Laboratories, Inc.
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tab
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Pump 371 14F LT CMR Set; Product Code: 0048-0045;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Howmedica Osteonics Corp.
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Food Recall · August 5, 2024
PBM Nutritionals, LLC
CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder; packaged in 964g composite cans; 4 cans per case; UPC 50428318034 and 41220164578
Product contains levels of Vitamin D above the maximum level permitted.
Class II
Medical Device Recall · August 5, 2024
MICROVENTION INC.
ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive v
Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella CP Smart Assist Set; Product Code: 1000402;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella 5.5 Set AU; Product Code: 1000361;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Drug Recall · August 5, 2024
Zeco LLC
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings R
CGMP Deviations: sterile water not used for production
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Drug Recall · August 5, 2024
Zeco LLC
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d)
CGMP Deviations: sterile water not used for production
Class II
Medical Device Recall · August 5, 2024
QUANTUM SURGICAL SAS
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrum
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Pump 381 Pump Set (US); Product Code: 1000080;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II
Medical Device Recall · August 5, 2024
Abiomed, Inc.
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Class II