PlainRecalls

2019 Recalls

Compiled from official public sources by the editorial team.

7,480 recalls · Page 8 of 150

2019 Recall Year Insight

Federal agencies issued 7,480 product recalls indexed by PlainRecalls in calendar year 2019. That represents about 7.35% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 20.5 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 150 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 7 critical, 41 moderate, and 2 lower-severity recalls. The page references 18 distinct recalling firms operating in 3 distinct product categories, with 25 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (24), FDA Drug (23), NHTSA (2), 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 Dec 11, 2019

Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 4…

Sanofi-Aventis U.S. LLC

FDA Drug Moderate Dec 11, 2019

fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West …

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, …

Sanofi-Aventis U.S. LLC

FDA Drug Moderate Dec 11, 2019

fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 7747…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar …

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167…

Sanofi-Aventis U.S. LLC

FDA Drug Moderate Dec 11, 2019

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.

Sanofi-Aventis U.S. LLC

FDA Drug Moderate Dec 11, 2019

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Phar…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 7747…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.

Sanofi-Aventis U.S. LLC

FDA Drug Moderate Dec 11, 2019

fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Ph…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597…

Sanofi-Aventis U.S. LLC

FDA Drug Moderate Dec 11, 2019

fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx, QuVA Pharm…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Pa…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 7…

QuVa Pharma, Inc.

FDA Drug Moderate Dec 11, 2019

Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.

Sanofi-Aventis U.S. LLC

FDA Drug Moderate Dec 11, 2019

fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 Wes…

QuVa Pharma, Inc.

FDA Devices Critical Dec 11, 2019

Synchromed II programmable pump, Model numbers 8637-20 and 8637-40

Medtronic Neuromodulation

FDA Devices Moderate Dec 11, 2019

Quantam 2000 Electrosurgical Generator, Part number 909075-05W.

CooperSurgical, Inc.

FDA Devices Moderate Dec 11, 2019

Quantam 2000 Electrosurgical Generator, Part number 909075.

CooperSurgical, Inc.

FDA Devices Low Dec 11, 2019

TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.

Theralase Inc.

FDA Devices Moderate Dec 11, 2019

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 …

Stryker Instruments Div. of Stryker Corporation

FDA Devices Critical Dec 11, 2019

Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer

GE Healthcare, LLC

FDA Devices Moderate Dec 11, 2019

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-13…

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Dec 11, 2019

Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam

Steris Corporation

FDA Devices Moderate Dec 11, 2019

EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1

NDDd Medical Technologies, Inc.

FDA Devices Moderate Dec 11, 2019

Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking c…

Miami Device Solutions, LLC.

FDA Devices Moderate Dec 11, 2019

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

Zimmer Biomet, Inc.

FDA Devices Moderate Dec 11, 2019

EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1

NDDd Medical Technologies, Inc.

FDA Devices Low Dec 11, 2019

TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.

Theralase Inc.

FDA Devices Moderate Dec 11, 2019

XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia mode…

Allergan PLC

FDA Devices Moderate Dec 11, 2019

BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended us…

Brasseler USA I Lp

FDA Devices Moderate Dec 11, 2019

HeartStart XL+ Defibrillator/Monitor, Model 861290

Philips North America, LLC

FDA Devices Moderate Dec 11, 2019

Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used…

Steris Corporation

FDA Devices Moderate Dec 11, 2019

Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is …

Lens.com

FDA Devices Moderate Dec 11, 2019

PANTERA Proximal Humerus Fracture Plate System

Toby Orthopaedics, Inc.

FDA Devices Moderate Dec 11, 2019

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

Zimmer Biomet, Inc.

FDA Devices Critical Dec 11, 2019

Giraffe OmniBed infant warmer

GE Healthcare, LLC

FDA Devices Critical Dec 11, 2019

Giraffe Incubator infant warmer

GE Healthcare, LLC

FDA Devices Critical Dec 11, 2019

Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warm…

GE Healthcare, LLC

FDA Devices Moderate Dec 11, 2019

Quantam 2000 Electrosurgical Generator, Part number 909075-05.

CooperSurgical, Inc.

CPSC Moderate Dec 11, 2019

Profile Design Recalls Bicycle Carbon Aerobars Due to Crash Hazard

NHTSA Critical Dec 11, 2019

BMW 2019-2020: POWER TRAIN:AUTOMATIC TRANSMISSION

BMW

NHTSA Critical Dec 11, 2019

FORD 2017-2019: STRUCTURE:BODY:ROOF AND PILLARS

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2019 across the FDA, CPSC and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.