PlainRecalls

2019 Recalls

7,396 recalls · Page 90 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 5 critical, 45 moderate, and 0 lower-severity recalls. The page references 23 distinct recalling firms operating in 2 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (49), CPSC (1), 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 Devices Moderate Jun 12, 2019

OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during …

OMNIlife science Inc.

FDA Devices Moderate Jun 12, 2019

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 12, 2019

Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable…

Stryker Corporation

FDA Devices Critical Jun 12, 2019

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F

OriGen Biomedical, Inc.

FDA Devices Moderate Jun 12, 2019

Sterile Nail Clipper Concave Edge (67710)

Centurion Medical Products Corporation

FDA Devices Moderate Jun 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)So…

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 12, 2019

MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and c…

Bio-Rad Laboratories, Inc

FDA Devices Moderate Jun 12, 2019

Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282

Cook Inc.

FDA Devices Moderate Jun 12, 2019

Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

Cook Inc.

FDA Devices Moderate Jun 12, 2019

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex …

Smiths Medical ASD Inc.

FDA Devices Moderate Jun 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Soler…

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 12, 2019

Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

FDA Devices Moderate Jun 12, 2019

NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that…

NxStage Medical, Inc.

FDA Devices Moderate Jun 12, 2019

Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRE…

Microbiologics Inc

FDA Devices Moderate Jun 12, 2019

Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolid…

I.T.S. GmbH

FDA Devices Moderate Jun 12, 2019

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 12, 2019

GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 7…

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Jun 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 …

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 12, 2019

Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.

Flowonix Medical Inc

FDA Devices Moderate Jun 12, 2019

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

Microline Surgical, Inc.

FDA Devices Critical Jun 12, 2019

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

OriGen Biomedical, Inc.

FDA Devices Moderate Jun 12, 2019

Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device inte…

Smiths Medical ASD Inc.

FDA Devices Moderate Jun 12, 2019

Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of…

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 12, 2019

MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinica…

Bio-Rad Laboratories, Inc

FDA Devices Moderate Jun 12, 2019

Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQ…

Microbiologics Inc

FDA Devices Moderate Jun 12, 2019

CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201…

Accuray Incorporated

FDA Devices Moderate Jun 12, 2019

Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alin…

Abbott Gmbh & Co. KG

FDA Devices Moderate Jun 12, 2019

Sterile Nail Nipper, Barrel Spring (I68400), Sterile

Centurion Medical Products Corporation

FDA Devices Moderate Jun 12, 2019

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 12, 2019

BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536

Becton Dickinson & Company

FDA Devices Moderate Jun 12, 2019

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium

Zimmer Biomet, Inc.

FDA Devices Critical Jun 12, 2019

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F

OriGen Biomedical, Inc.

FDA Devices Moderate Jun 12, 2019

NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy sys…

NxStage Medical, Inc.

FDA Devices Moderate Jun 12, 2019

IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional…

Philips North America, LLC

FDA Devices Moderate Jun 12, 2019

Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For int…

Flowonix Medical Inc

FDA Devices Moderate Jun 12, 2019

Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) appl…

Leica Microsystems, Inc.

FDA Devices Moderate Jun 12, 2019

Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal …

Flowonix Medical Inc

FDA Devices Critical Jun 12, 2019

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F

OriGen Biomedical, Inc.

FDA Devices Moderate Jun 12, 2019

Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.

Flowonix Medical Inc

FDA Devices Critical Jun 12, 2019

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F

OriGen Biomedical, Inc.

FDA Devices Moderate Jun 12, 2019

IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, an…

Philips North America, LLC

FDA Devices Moderate Jun 12, 2019

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase 3 Femoral Drill Guide Extra Large

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 12, 2019

Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, …

Stryker Neurovascular

FDA Devices Moderate Jun 12, 2019

IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a trad…

Philips North America, LLC

FDA Devices Moderate Jun 12, 2019

Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.

Flowonix Medical Inc

FDA Devices Moderate Jun 12, 2019

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 12, 2019

CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Rad…

Accuray Incorporated

FDA Devices Moderate Jun 12, 2019

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Sol…

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Jun 12, 2019

Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, R…

Stryker Corporation

CPSC Moderate Jun 12, 2019

Hayward Industries Recalls Pool Heater Vent Kits Due to Carbon Monoxide Poisoning Hazard

Hayward Industries Inc, of Nashville, Tenn.

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