PlainRecalls

2019 Recall Year Insight

Federal agencies issued 7,611 product recalls indexed by PlainRecalls in calendar year 2019. That represents about 7.29% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 20.9 recalls per day across the FDA, CPSC, USDA FSIS, 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 153 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 15 critical, 33 moderate, and 2 lower-severity recalls. The page references 15 distinct recalling firms operating in 3 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (41), FDA Drug (9), 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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Low Sep 18, 2019

Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10

Macleods Pharma Usa Inc

FDA Drug Moderate Sep 18, 2019

Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03

Pfizer Inc.

FDA Drug Moderate Sep 18, 2019

10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles

Compounded Solutions in Pharmacy

FDA Drug Low Sep 18, 2019

Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH

American Health Packaging

FDA Drug Critical Sep 18, 2019

Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

Plastikon Healthcare LLC

FDA Drug Moderate Sep 18, 2019

20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.

Compounded Solutions in Pharmacy

FDA Drug Moderate Sep 18, 2019

Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901

Pacifico National, Inc. dba AmEx Pharmacy

FDA Drug Moderate Sep 18, 2019

5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles

Compounded Solutions in Pharmacy

FDA Drug Moderate Sep 18, 2019

AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

AVKARE Inc.

FDA Devices Moderate Sep 18, 2019

Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Critical Sep 18, 2019

Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,168-420,168-450,168-480,168-510,168-550,168-600, 168-650,168-700,168-750, 168-800; Style 363: 363LF-170, 363LF-200, 363LF-230, 363LF-260, 363LF-300, 363LF-330, 363LF-370, 363LF-410, 363LF-450, 363LF-510, 363LF-560, 363

Allergan PLC

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal tube/airway management

Teleflex Medical

FDA Devices Moderate Sep 18, 2019

XP-XP Tibial Tray - Interlok 79 mm Item # 195758

Zimmer Biomet, Inc.

FDA Devices Critical Sep 18, 2019

Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11, 133P-FV-12, 133P-FV-13, 133P-FV-14, 133P-FV-15, 133P-FV-16; STYLE 133P-MV: 133P-MV-11, 133P-MV-12, 133P-MV-13, 133P-MV-14, 133P-MV-15, 133P-MV-16; STYLE 133P-LV: 133P-LV-11, 133P-LV-12, 133P-LV-13, 133P-LV-14, 133P-LV-15, 133P-LV-16; STYLE 133P-FX: 133P-FX-11,

Allergan PLC

FDA Devices Critical Sep 18, 2019

Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction

Allergan PLC

FDA Devices Moderate Sep 18, 2019

XP-XP Tibial Tray - Interlok 65 mm Item # 195752

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291

Zimmer Biomet, Inc.

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usage: Tracheal tube/airway management

Teleflex Medical

FDA Devices Moderate Sep 18, 2019

Vanguard XP Tibial Tray 75 mm Item # 195251

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

XP-XP Tibial Tray - Interlok 59 mm Item # 195750

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

ROTEM ex-tem Canada Part No: 503-05-CA

Instrumentation Laboratory Co.

FDA Devices Moderate Sep 18, 2019

Vanguard XP Tibial Tray 63 mm Item # 195245

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

Smith & Nephew, Inc.

FDA Devices Moderate Sep 18, 2019

XP-CR Tibial Tray - Interlok 75mm Item # 195275

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

XP-CR Tibial Tray - Interlok 87 mm Item # 195278

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

Vanguard XP Tibial Tray 73 mm Item # 195250

Zimmer Biomet, Inc.

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-10213 I) 7.0 mm, REF 5-10114, REF 5-10214 j) 7.5 mm, REF V5-10115, REF 5-10115, REF 5-10215 k) 8.0 mm, REF 5-10116, REF 5-10216, REF V5-10116 l) 8.5 mm, REF 5-10117, REF 5-10217 m) 9.0 mm, REF 5-10118, REF5-10218 n) 9.

Teleflex Medical

FDA Devices Moderate Sep 18, 2019

XP-XP Tibial Tray - Interlok 83 mm Item # 195759

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

ROTEM ex-tem Rest of the world part No: 503-05 (ROW)

Instrumentation Laboratory Co.

FDA Devices Moderate Sep 18, 2019

XP-XP Tibial Tray - Interlok 73 mm Item # 195756

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation. Users may als

Philips North America, LLC

FDA Devices Moderate Sep 18, 2019

XP-CR Tibial Tray - Interlok 91 mm Item # 195279

Zimmer Biomet, Inc.

FDA Devices Critical Sep 18, 2019

Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction

Allergan PLC

FDA Devices Moderate Sep 18, 2019

Vanguard XP Tibial Tray 79 mm Item # 195252

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.

Stryker Communications

FDA Devices Moderate Sep 18, 2019

Vanguard XP Tibial Tray 67 mm Item # 195247

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

XP-CR Tibial Tray - Interlok 83 mm Item # 195277

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 18, 2019

ROTEM ex-tem; US Part No: 503-05-US

Instrumentation Laboratory Co.

FDA Devices Moderate Sep 18, 2019

Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration

Philips North America, LLC

FDA Devices Moderate Sep 18, 2019

Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.

Stryker Communications

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210 f) 5.5 mm, REF 5-22011, REF 5-22111, REF 5-22211 g) 6.0 mm, REF 5-22212, REF 5-22312, REF 5-22112 h) 6.5 mm, REF 5-22313, REF 5-22213, REF 5-22013, REF 5-22113 i) 7.0 mm, REF 5-22214, REF 5-22314, REF 5-22014, REF 5-22114 j) 7.5 mm, REF 5-2

Teleflex Medical

FDA Devices Critical Sep 18, 2019

Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augmentation and Breast reconstruction

Allergan PLC

FDA Devices Moderate Sep 18, 2019

XP-XP Tibial Tray - Interlok 69 mm Item # 195754

Zimmer Biomet, Inc.

FDA Devices Critical Sep 18, 2019

Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TRL-560,TRL-610; Style TRLP: TRLP-125TRLP-145,TRLP-165,TRLP-190,TRLP-205,TRLP-220,TRLP-235,TRLP-250, TRLP-265,TRLP-280,TRLP-300,TRLP-320,TRLP-340,TRLP-360,TRLP-400,TRLP-440,TRLP-490,TRLP-540,TRLP-590,TRLP-640; Style TRM: TRM-140,TRM-175,TRM-195,TRM-210,TRM-240,TRM-255,TRM-275,

Allergan PLC

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10411 i) 6.0 mm, REF 5-10412 j) 6.5 mm, REF 5-10413 k) 7.0 mm, REF 5-10414 Product Usage: Tracheal tube/airway management

Teleflex Medical

FDA Devices Critical Sep 18, 2019

Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Breast augmentation and Breast reconstruction

Allergan PLC

FDA Devices Moderate Sep 18, 2019

Vanguard XP Tibial Tray 65 mm Item # 195246

Zimmer Biomet, Inc.

FDA Devices Critical Sep 18, 2019

McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

Allergan PLC

FDA Devices Critical Sep 18, 2019

Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management

Teleflex Medical

FDA Devices Moderate Sep 18, 2019

XP-CR Tibial Tray - Interlok 63mm Item # 195269

Zimmer Biomet, 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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2019

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2019 across the FDA, CPSC, USDA FSIS 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 September 2026.