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 0 critical, 50 moderate, and 0 lower-severity recalls. The page references 15 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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 Devices Moderate Oct 16, 2019

BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes

Becton, Dickinson and Company, BD Biosciences

FDA Devices Moderate Oct 16, 2019

BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985

Becton Dickinson & Company

FDA Devices Moderate Oct 16, 2019

BD Microtainer SST- Amber Part/Catalog Number: 365978

Becton Dickinson & Company

FDA Devices Moderate Oct 16, 2019

STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture

Ethicon, Inc.

FDA Devices Moderate Oct 16, 2019

BD Microtainer SST Part/Catalog No.365967

Becton Dickinson & Company

FDA Devices Moderate Oct 16, 2019

Achilles Express Bone Sonometer

GE Healthcare, LLC

FDA Devices Moderate Oct 16, 2019

Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers pr

Ohmeda Medical

FDA Devices Moderate Oct 16, 2019

BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes

Becton, Dickinson and Company, BD Biosciences

FDA Devices Moderate Oct 16, 2019

PICC Line Accessory Kit CVI4285

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac im

AZIYO BIOLOGICS

FDA Devices Moderate Oct 16, 2019

NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

Neonatal Cap Change Kit DT20315

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

CVC BUNDLE, 20CM, 3L, PI ECVC5120

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

Cap Change Kit DT20310

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

CVC BUNDLE WITHOUT CATH CVI4600

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their standard surgical technique.

K2M, Inc

FDA Devices Moderate Oct 16, 2019

20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

Repro-Med Systems, Inc.

FDA Devices Moderate Oct 16, 2019

BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes

Becton, Dickinson and Company, BD Biosciences

FDA Devices Moderate Oct 16, 2019

CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is in

AZIYO BIOLOGICS

FDA Devices Moderate Oct 16, 2019

BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes

Becton, Dickinson and Company, BD Biosciences

FDA Devices Moderate Oct 16, 2019

BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987

Becton Dickinson & Company

FDA Devices Moderate Oct 16, 2019

CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes

Becton, Dickinson and Company, BD Biosciences

FDA Devices Moderate Oct 16, 2019

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Helena Laboratories, Corp.

FDA Devices Moderate Oct 16, 2019

CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

CVC BUNDLE, 20CM, 4L, PI ECVC5095

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

Conformis, Inc.

FDA Devices Moderate Oct 16, 2019

Achilles Insight Bone Sonometer

GE Healthcare, LLC

FDA Devices Moderate Oct 16, 2019

INVASIVE PROCEDURE TRAY MNS9510

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.

Leica Biosystems Imaging, Inc.

FDA Devices Moderate Oct 16, 2019

CVC BUNDLE, 20CM, 3L, PI ECVC5120A

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

INFUSA PORT KIT DYNDC1840E

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.

TriMed Inc.

FDA Devices Moderate Oct 16, 2019

CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963

Becton Dickinson & Company

FDA Devices Moderate Oct 16, 2019

YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm) Catalog Numbers 7601-03512, 7601-03514, 7601-03532, 7601-03534, 7601-03538L, 7601-03540L, 7601-04016L, 7601-04018L, 7601-04020L, 7601-04022L, 7601-04024L, 7601-04026L, 7601-04028L, 7601-04030, 7601-05022, 7601-05028,

K2M, Inc

FDA Devices Moderate Oct 16, 2019

IV SECUREMENT KIT IVS3405

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

CAP CHANGE KIT DYNDC1496B

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes

Becton, Dickinson and Company, BD Biosciences

FDA Devices Moderate Oct 16, 2019

STERILE CAP CHANGE KIT DYNDC1946B

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

Vital Scientific N.V.

FDA Devices Moderate Oct 16, 2019

TRIPLE LUMEN BUNDLE KIT ECVC1540

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

INFUSA PORT KIT DYNDC1840F

Centurion Medical Products Corporation

FDA Devices Moderate Oct 16, 2019

cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Oct 16, 2019

Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR

Centurion Medical Products Corporation

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.