PlainRecalls

2019 Recalls

7,396 recalls · Page 112 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 0 critical, 43 moderate, and 7 lower-severity recalls. The page references 26 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (29), FDA Drug (21), 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 Apr 17, 2019

PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Moderate Apr 17, 2019

LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), per bot…

Torrent Pharma Inc.

FDA Drug Low Apr 17, 2019

Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8 mL vial, Rx Only, M…

Medi-Physics Inc. dba GE Healthcare

FDA Drug Moderate Apr 17, 2019

Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ…

Glenmark Pharmaceuticals Inc., USA

FDA Drug Moderate Apr 17, 2019

PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvalli…

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Moderate Apr 17, 2019

PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding Pharmacy, 996 NW Circle Bl…

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Moderate Apr 17, 2019

LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Tor…

Torrent Pharma Inc.

FDA Drug Moderate Apr 17, 2019

PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 9733…

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Moderate Apr 17, 2019

Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC 1775 US Hwy 385 806-647-1741 Dimmitt, TX 79027

McDaniel Life-Line LLC

FDA Drug Moderate Apr 17, 2019

PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corva…

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Low Apr 17, 2019

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30

AVKARE Inc.

FDA Drug Low Apr 17, 2019

Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, N…

X-Gen Pharmaceuticals Inc.

FDA Drug Moderate Apr 17, 2019

Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debosse…

H J Harkins Company Inc dba Pharma Pac

FDA Drug Moderate Apr 17, 2019

HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Co…

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Moderate Apr 17, 2019

PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW C…

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Moderate Apr 17, 2019

PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Moderate Apr 17, 2019

PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Moderate Apr 17, 2019

PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 973…

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Moderate Apr 17, 2019

Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (…

Torrent Pharma Inc.

FDA Drug Moderate Apr 17, 2019

PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

FDA Drug Low Apr 17, 2019

Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.

Auro Pharmacies Inc. DBA Central Drugs

FDA Devices Moderate Apr 17, 2019

Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07

Becton Dickinson & Company

FDA Devices Moderate Apr 17, 2019

iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: …

Conformis, Inc.

FDA Devices Moderate Apr 17, 2019

Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation thera…

Elekta Limited

FDA Devices Low Apr 17, 2019

Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality…

Randox Laboratories Ltd.

FDA Devices Moderate Apr 17, 2019

COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albu…

Roche Diagnostics Corporation

FDA Devices Moderate Apr 17, 2019

SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine…

LivaNova USA Inc.

FDA Devices Moderate Apr 17, 2019

CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in C…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Apr 17, 2019

ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.

Johnson & Johnson Vision Care, Inc.

FDA Devices Moderate Apr 17, 2019

Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.

Vygon U.S.A.

FDA Devices Moderate Apr 17, 2019

Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support t…

Integra Limited

FDA Devices Moderate Apr 17, 2019

ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.

ulrich medical USA Inc

FDA Devices Moderate Apr 17, 2019

Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. T…

Abbott Laboratories, Inc

FDA Devices Low Apr 17, 2019

Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed qua…

Randox Laboratories Ltd.

FDA Devices Moderate Apr 17, 2019

BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

Becton Dickinson & Company

FDA Devices Moderate Apr 17, 2019

cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Cat…

Roche Diagnostics Corporation

FDA Devices Moderate Apr 17, 2019

Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. …

Abbott Laboratories, Inc

FDA Devices Moderate Apr 17, 2019

CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL t…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Apr 17, 2019

Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support …

Integra Limited

FDA Devices Moderate Apr 17, 2019

Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.

Vygon U.S.A.

FDA Devices Moderate Apr 17, 2019

AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Dev…

PROCEPT BIOROBOTICS CORPORATION

FDA Devices Low Apr 17, 2019

Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assaye…

Randox Laboratories Ltd.

FDA Devices Moderate Apr 17, 2019

Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support …

Integra Limited

FDA Devices Moderate Apr 17, 2019

Azurion FlexArm, 722079

Philips North America, LLC

FDA Devices Moderate Apr 17, 2019

CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAI…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Apr 17, 2019

Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396

Arrow International Inc

FDA Devices Moderate Apr 17, 2019

Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. T…

Abbott Laboratories, Inc

FDA Devices Moderate Apr 17, 2019

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Opht…

Beaver Visitec

FDA Devices Moderate Apr 17, 2019

Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric …

Edwards Lifesciences, LLC

FDA Devices Moderate Apr 17, 2019

Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132

Arrow International Inc

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