PlainRecalls

2020 Recalls

4,819 recalls · Page 31 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 1 critical, 48 moderate, and 1 lower-severity recalls. The page references 16 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 Critical Sep 2, 2020

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceut…

SCA Pharmaceuticals

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visual…

Karl Storz Endoscopy

FDA Devices Moderate Sep 2, 2020

Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and v…

Karl Storz Endoscopy

FDA Devices Moderate Sep 2, 2020

Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: …

Neurovision Medical Products Inc

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and sta…

Neurovision Medical Products Inc

FDA Devices Moderate Sep 2, 2020

Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac …

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Prod…

Ortho-Clinical Diagnostics

FDA Devices Moderate Sep 2, 2020

CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electroph…

Biosense Webster (israel), Ltd.

FDA Devices Moderate Sep 2, 2020

VITROS XT7600 Integrated System, Product code 6844461

Ortho Clinical Diagnostics

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acu…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-0…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, usin…

Siemens Medical Solutions USA, Inc.

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring a…

Neurovision Medical Products Inc

FDA Devices Moderate Sep 2, 2020

Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visual…

Karl Storz Endoscopy

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring …

Neurovision Medical Products Inc

FDA Devices Moderate Sep 2, 2020

VITROS XT3400 Chemistry System, Product code 6844458

Ortho Clinical Diagnostics

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visual…

Karl Storz Endoscopy

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: A…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and trea…

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Sep 2, 2020

LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

89 NORTH

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Prod…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack

Becton Dickinson & Company

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: A…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and v…

Karl Storz Endoscopy

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿

Globus Medical, Inc.

FDA Devices Low Sep 2, 2020

Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepi…

OraSure Technologies, Inc.

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Co…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobil…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Sep 2, 2020

VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and …

Ortho-Clinical Diagnostics

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿

Globus Medical, Inc.

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 06…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: A…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-05…

Datascope Corporation

FDA Devices Moderate Sep 2, 2020

Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medica…

Klarity Medical Products LLC

FDA Devices Moderate Sep 2, 2020

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

Conformis, Inc.

FDA Devices Moderate Sep 2, 2020

Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: …

Neurovision Medical Products 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