PlainRecalls

2019 Recalls

7,396 recalls · Page 106 of 148

2019 Recall Year Insight

Federal agencies issued 7,396 product recalls indexed by PlainRecalls in calendar year 2019. That represents about 8.81% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 20.3 recalls per day across the FDA, CPSC, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 148 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2019.

On this page of 50 records, severity classification shows 6 critical, 39 moderate, and 5 lower-severity recalls. The page references 27 distinct recalling firms operating in 8 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (22), FDA Drug (20), CPSC (4), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ — an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2019 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number — always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate May 1, 2019

Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Low May 1, 2019

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactur…

LUPIN SOMERSET

FDA Drug Moderate May 1, 2019

Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Sui…

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC,…

CMC Enterprise Pharmacy

FDA Drug Low May 1, 2019

Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (…

Zydus Pharmaceuticals USA Inc

FDA Drug Moderate May 1, 2019

CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Low May 1, 2019

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL…

Akorn Inc

FDA Drug Moderate May 1, 2019

Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC…

CMC Enterprise Pharmacy

FDA Drug Moderate May 1, 2019

Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

CMC Enterprise Pharmacy

FDA Devices Moderate May 1, 2019

OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The d…

Carestream Health, Inc.

FDA Devices Moderate May 1, 2019

Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - …

Thoratec Corp.

FDA Devices Critical May 1, 2019

Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrioseptostomy c…

Edwards Lifesciences, LLC

FDA Devices Moderate May 1, 2019

Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotatin…

COVIDIEN LLC

FDA Devices Moderate May 1, 2019

VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use…

Ortho-Clinical Diagnostics

FDA Devices Moderate May 1, 2019

Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression …

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 1, 2019

Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a varie…

COVIDIEN LLC

FDA Devices Critical May 1, 2019

Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptost…

Edwards Lifesciences, LLC

FDA Devices Moderate May 1, 2019

cone-beam CT system

KaVo Dental Technologies LLC

FDA Devices Moderate May 1, 2019

CryoPatch SG Pulmonary Hemi-Artery Patch

CryoLife, Inc.

FDA Devices Moderate May 1, 2019

Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and …

Arthrex, Inc.

FDA Devices Low May 1, 2019

Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

Cytocell Ltd.

FDA Devices Moderate May 1, 2019

Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECI…

COVIDIEN LLC

FDA Devices Moderate May 1, 2019

Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, …

Guangzhou Improve Medical Instruments Co., Ltd.

FDA Devices Moderate May 1, 2019

TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw i…

TriMed Inc.

FDA Devices Moderate May 1, 2019

RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements appl…

Brainlab AG

FDA Devices Moderate May 1, 2019

Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer s…

Exactech, Inc.

FDA Devices Moderate May 1, 2019

St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac mo…

Abbott

FDA Devices Low May 1, 2019

Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a sing…

GETINGE US SALES LLC

FDA Devices Moderate May 1, 2019

Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotr…

Fenwal Inc

FDA Devices Moderate May 1, 2019

Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. cath…

Smiths Medical ASD Inc.

FDA Devices Moderate May 1, 2019

Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and …

Stryker Instruments Div. of Stryker Corporation

CPSC Moderate May 1, 2019

DAVIDsTEA Recalls Valentine’s Day Stackable Mugs Due to Fire Hazard

Lynns Concepts Ltd., of Hong Kong

CPSC Moderate May 1, 2019

Starbucks Recalls Bodum Recycled Coffee Presses Due to Laceration Hazard

NHTSA Critical May 1, 2019

KENWORTH,PETERBILT 2020: VISIBILITY:REARVIEW MIRRORS/DEVICES:EXTERIOR

KENWORTH,PETERBILT

CPSC Moderate Apr 30, 2019

Tween Brands Recalls Light Up Bed Canopies Due to Fire and Burn Hazards; Sold Exclusively at Justice (Recall Alert)

NHTSA Critical Apr 29, 2019

FORD 2014-2018: SEATS

FORD

CPSC Moderate Apr 26, 2019

Kids II Recalls All Rocking Sleepers Due to Reports of Deaths

NHTSA Critical Apr 26, 2019

MITSUBISHI 2017-2018: AIR BAGS

MITSUBISHI

NHTSA Critical Apr 26, 2019

FORD 2015-2018: SEATS

FORD

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2019 with 2018 →

Data Sources

  • Source: FDA openFDA Enforcement API — calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA — consumer product and vehicle recall feeds for 2019