PlainRecalls

2020 Recalls

4,819 recalls · Page 54 of 97

2020 Recall Year Insight

Federal agencies issued 4,819 product recalls indexed by PlainRecalls in calendar year 2020. That represents about 5.74% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 13.2 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 97 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 2020.

On this page of 50 records, severity classification shows 0 critical, 48 moderate, and 2 lower-severity recalls. The page references 17 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (49), FDA Drug (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 2020 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 Drug Moderate May 27, 2020

Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC…

Mylan Institutional LLC

FDA Devices Moderate May 27, 2020

Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained …

Philips North America, LLC

FDA Devices Moderate May 27, 2020

TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63…

Baylis Medical Company Inc.

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Siz…

K2M, Inc

FDA Devices Moderate May 27, 2020

Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative…

Cardinal Health Inc.

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during ca…

Applied Medical Resources Corp

FDA Devices Moderate May 27, 2020

Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for t…

Skeletal Kinetics, Llc

FDA Devices Low May 27, 2020

Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SL…

Pega Medical Inc.

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Siz…

K2M, Inc

FDA Devices Moderate May 27, 2020

SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is in…

Medline Industries Inc

FDA Devices Moderate May 27, 2020

SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is …

Medline Industries Inc

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

Prismaflex Control Unit

Baxter Healthcare Corporation

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reage…

Becton Dickinson & Co.

FDA Devices Moderate May 27, 2020

BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277

Becton Dickinson & Company

FDA Devices Moderate May 27, 2020

The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a…

The Binding Site Group, Ltd.

FDA Devices Moderate May 27, 2020

BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435

Becton Dickinson & Company

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545…

Baylis Medical Company Inc.

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 10888857108943, Siz…

K2M, Inc

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Siz…

K2M, Inc

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during ca…

Applied Medical Resources Corp

FDA Devices Moderate May 27, 2020

CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus vi…

Capso Vision, Inc.

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 10888857108684, Siz…

K2M, Inc

FDA Devices Moderate May 27, 2020

Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.

Clinical Innovations, LLC

FDA Devices Moderate May 27, 2020

HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: …

Philips North America, LLC

FDA Devices Moderate May 27, 2020

BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A

Becton Dickinson & Company

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Siz…

K2M, Inc

FDA Devices Moderate May 27, 2020

BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276

Becton Dickinson & Company

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278

Becton Dickinson & Company

FDA Devices Moderate May 27, 2020

STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during ca…

Applied Medical Resources Corp

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 10888857108660, Siz…

K2M, Inc

FDA Devices Moderate May 27, 2020

BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagen…

Becton Dickinson & Co.

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 10888857108905, Siz…

K2M, Inc

FDA Devices Moderate May 27, 2020

BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535

Becton Dickinson & Company

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Siz…

K2M, Inc

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Siz…

K2M, Inc

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 10888857108202, Siz…

K2M, Inc

FDA Devices Low May 27, 2020

ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical trea…

Immersivetouch Inc

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B

Becton Dickinson & Company

FDA Devices Moderate May 27, 2020

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)

Howmedica Osteonics Corp.

FDA Devices Moderate May 27, 2020

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 10888857108806, Siz…

K2M, Inc

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2020 with 2019 →

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 2020