DrugJul 26, 2023
SterRx Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL recall — FDA D-0933-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedSterRx, LLC
Latest records
Latest recalls — page 536
The newest recall records with useful source details are listed here.
DrugJul 26, 2023
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton recall — FDA D-0939-2023
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class IIFDA: TerminatedGlenmark Therapeutics, Inc.
DrugJul 26, 2023
SterRx Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL) recall — FDA D-0930-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedSterRx, LLC
DrugJul 26, 2023
New England Life Care, Inc. dba Advanced ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL recall — FDA D-0928-2023
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class IIFDA: TerminatedNew England Life Care, Inc. dba Advanced Compounding…
DrugJul 26, 2023
New England Life Care, Inc. dba Advanced Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride recall — FDA D-0929-2023
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class IIFDA: TerminatedNew England Life Care, Inc. dba Advanced Compounding…
DrugJul 26, 2023
SterRx Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single recall — FDA D-0931-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedSterRx, LLC
VehicleJul 21, 2023
Ford instrument cluster/panel recall — NHTSA campaign 23V506000
Ford Motor Company (Ford) is recalling certain 2023 Escape, Super Duty F-250, Super Duty F-350, Super Duty F-450, and Super Duty F-550 vehicles equipped with a digital instrument panel…
instrument cluster/panelFord Motor Company
VehicleJul 21, 2023
F-150 electrical recall — NHTSA campaign 23V509000
Ford Motor Company (Ford) is recalling certain 2021-2023 F-150 vehicles equipped with a single exhaust system. Contact with the rear axle housing may damage the wiring harness, causing the…
electricalFord Motor Company
Medical DeviceJul 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model recall — FDA Z-2136-2023
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceJul 19, 2023
Beckman Coulter COULTER DxH Diluent, REF 628017 recall — FDA Z-2138-2023
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Class IIFDA: OngoingBeckman Coulter, Inc.
Medical DeviceJul 19, 2023
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous recall — FDA Z-2110-2023
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
Class IFDA: OngoingAbbott
Medical DeviceJul 19, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522 recall — FDA Z-2119-2023
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two…
Class IIFDA: OngoingMedtronic Sofamor Danek USA Inc.
Medical DeviceJul 19, 2023
Ortho-Clinical Diagnostics VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic recall — FDA Z-2129-2023
Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the…
Class IIFDA: OngoingOrtho-Clinical Diagnostics
Medical DeviceJul 19, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525 recall — FDA Z-2120-2023
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two…
Class IIFDA: OngoingMedtronic Sofamor Danek USA Inc.
Medical DeviceJul 19, 2023
HeartSine Technologies HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold recall — FDA Z-2143-2023
Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering…
Class IIFDA: OngoingHeartSine Technologies Ltd
Medical DeviceJul 19, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322 recall — FDA Z-2117-2023
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two…
Class IIFDA: OngoingMedtronic Sofamor Danek USA Inc.
Medical DeviceJul 19, 2023
Baxter Healthcare SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 recall — FDA Z-2103-2023
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 19, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325 recall — FDA Z-2118-2023
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two…
Class IIFDA: OngoingMedtronic Sofamor Danek USA Inc.
Medical DeviceJul 19, 2023
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 recall — FDA Z-2128-2023
There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that…
Class IIFDA: OngoingAbiomed, Inc.
Medical DeviceJul 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number recall — FDA Z-2137-2023
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceJul 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number recall — FDA Z-2135-2023
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceJul 19, 2023
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725 recall — FDA Z-2122-2023
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two…
Class IIFDA: OngoingMedtronic Sofamor Danek USA Inc.
Medical DeviceJul 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number recall — FDA Z-2132-2023
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceJul 19, 2023
Baxter Healthcare Allen Advance Chest Support with Pad recall — FDA Z-2109-2023
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
Class IIFDA: OngoingBaxter Healthcare Corporation
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
September 2026364 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categoriesOctober 2025455 records · 4 categories