PlainRecalls

2019 Recalls

7,396 recalls · Page 97 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 4 critical, 46 moderate, and 0 lower-severity recalls. The page references 17 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (45), FDA Drug (5), 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 May 29, 2019

Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated

Golden State Medical Supply Inc.

FDA Drug Moderate May 29, 2019

Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutic…

Septodont Inc.

FDA Drug Moderate May 29, 2019

Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 10…

Heritage Pharmaceuticals, Inc.

FDA Drug Moderate May 29, 2019

Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60

MALLINCKRODT PHARMACEUTICALS

FDA Drug Critical May 29, 2019

Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by:…

Novartis Pharmaceuticals Corp.

FDA Devices Moderate May 29, 2019

V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill, contra-angle, 1.5x85mm, Item Number ST502015706

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill, cannulated, 3x90mm, AO, Item Number ST502015631

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G1483…

Cook Inc.

FDA Devices Moderate May 29, 2019

CBS micro, countersink, cannulated, round-shaft, Item Number 503004341

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114

Zimmer GmbH

FDA Devices Moderate May 29, 2019

AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a …

Boston Scientific Corporation

FDA Devices Moderate May 29, 2019

Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultiva…

Remel Inc

FDA Devices Moderate May 29, 2019

Drill, cannulated, 2.5x95mm, AO, Item Number 502015621

Zimmer GmbH

FDA Devices Critical May 29, 2019

UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 80…

Beckman Coulter Inc.

FDA Devices Moderate May 29, 2019

Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill, cannulated, 2.8x150mm, AO, Item Number 502015629

Zimmer GmbH

FDA Devices Moderate May 29, 2019

V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638

Zimmer GmbH

FDA Devices Moderate May 29, 2019

CHOL+HDL+GLU test strips, REF 2412

Polymer Technology Systems, Inc.

FDA Devices Moderate May 29, 2019

Drill, cannulated, 3x90mm, round shaft, Item Number 502015630

Zimmer GmbH

FDA Devices Moderate May 29, 2019

CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 mi…

Dornier Medtech America, Inc.

FDA Devices Moderate May 29, 2019

EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, E…

Stryker Communications

FDA Devices Moderate May 29, 2019

Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 …

Cook Inc.

FDA Devices Moderate May 29, 2019

Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill, cannulated, 4x120mm, AO, Item Number ST502015402

Zimmer GmbH

FDA Devices Moderate May 29, 2019

AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including …

Boston Scientific Corporation

FDA Devices Moderate May 29, 2019

Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120

Zimmer GmbH

FDA Devices Moderate May 29, 2019

CBS 7.5 tap, cannulated, AO, Item Number 503002041

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation …

Remel Inc

FDA Devices Moderate May 29, 2019

Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reus…

Thommen Medical AG

FDA Devices Moderate May 29, 2019

Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation …

Remel Inc

FDA Devices Moderate May 29, 2019

Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation…

Remel Inc

FDA Devices Moderate May 29, 2019

Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216

Zimmer GmbH

FDA Devices Moderate May 29, 2019

DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental int…

KaVo Dental Technologies LLC

FDA Devices Moderate May 29, 2019

Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145

Zimmer GmbH

FDA Devices Moderate May 29, 2019

V-TEK", Micro-countersink, AO, Item Number 28.66.113

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

Elekta Instrument AB

FDA Devices Moderate May 29, 2019

Drill, cannulated, 2x95mm, round shaft, Item Number 502015619

Zimmer GmbH

FDA Devices Critical May 29, 2019

UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument a…

Beckman Coulter Inc.

FDA Devices Moderate May 29, 2019

CBS high, countersink, cannulated, round-shaft, Item Number 503004342

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill, cannulated, 2.8x120mm, AO, Item Number 502015628

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill, 2.5x135mm, AO, Item Number 502015142

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivat…

Remel Inc

FDA Devices Moderate May 29, 2019

Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

Polymer Technology Systems, Inc.

FDA Devices Moderate May 29, 2019

Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640

Zimmer GmbH

FDA Devices Moderate May 29, 2019

CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351

Zimmer GmbH

FDA Devices Critical May 29, 2019

MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Sy…

Integra LifeSciences Corp.

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