PlainRecalls

2019 Recalls

6,365 recalls · Page 18 of 128

2019 Recall Year Insight

Federal agencies issued 6,365 product recalls indexed by PlainRecalls in calendar year 2019. That represents about 7.58% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 17.4 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 128 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 4 critical, 45 moderate, and 1 lower-severity recalls. The page references 25 distinct recalling firms operating in 5 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (41), CPSC (5), NHTSA (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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTI…

Cadence Science, Inc.

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

Universal Sexual Health Testing Kit

Privapath Diagnostics Ltd

FDA Devices Moderate Nov 20, 2019

TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

TriMed Inc.

FDA Devices Moderate Nov 20, 2019

Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a m…

Galil Medical, Inc.

FDA Devices Moderate Nov 20, 2019

TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

TriMed Inc.

FDA Devices Low Nov 20, 2019

RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.

Randox Laboratories, Limited

FDA Devices Moderate Nov 20, 2019

TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

TriMed Inc.

FDA Devices Moderate Nov 20, 2019

Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (I…

Canon Medical System, USA, INC.

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

Monarch Medical Technologies

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation S…

Tec Com Gmbh

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes…

Carroll-Baccari, Inc.

FDA Devices Moderate Nov 20, 2019

Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301

Draegar Medical Systems, Inc.

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple …

Smith & Nephew, Inc.

FDA Devices Moderate Nov 20, 2019

2000 Vascular with 30 Degree option

Heritage Medical Products, Inc.

FDA Devices Moderate Nov 20, 2019

Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

Implant Direct Sybron Manufacturing, LLC

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handl…

Synthes (USA) Products LLC

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)

Basic Reset Inc.

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF6…

Tornier, Inc

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298

Orthofix Srl

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915

Orthofix Srl

CPSC Moderate Nov 20, 2019

B&B Acquisition Recalls Wintergreen Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning

B&B Acquisition, of Salt Lake City, Utah

CPSC Moderate Nov 20, 2019

Deck Source Recalls Cutek Proclean Due to Violation of FHSA Labeling Requirements; Risk of Poisoning

Chemisys International Pty Ltd, of Australia

CPSC Moderate Nov 20, 2019

Grace Digital Recalls EcoBoulder Speakers That Can Overcharge and Burst; Impact Hazard

NHTSA Critical Nov 20, 2019

CHEVROLET 2019: WHEELS:LUGS/NUTS/BOLTS/STUDS

CHEVROLET

CPSC Moderate Nov 19, 2019

Flying Tiger Copenhagen Recalls Crocodile Candleholders Due to Fire Hazard

Tiger Retail East Coast LLC, of New York

CPSC Moderate Nov 19, 2019

United National Closeout Stores Recalls Isometric Exercise Devices Due to Projectile Hazard; Devices Sold at Burlington Stores After 2014 Recall

UNCS, of Fort Lauderdale, Fla.

NHTSA Critical Nov 18, 2019

BMW 2015-2019: CHILD SEAT

BMW

NHTSA Critical Nov 18, 2019

MERCEDES-BENZ 2019: STEERING:ELECTRIC POWER ASSIST SYSTEM

MERCEDES-BENZ

NHTSA Critical Nov 15, 2019

MERCEDES-BENZ 2018-2019: ENGINE AND ENGINE COOLING:ENGINE:GASOLINE

MERCEDES-BENZ

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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2019