PlainRecalls

2021 Recalls

5,168 recalls · Page 39 of 104

2021 Recall Year Insight

Federal agencies issued 5,168 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.08% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 14.2 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 104 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 2021.

On this page of 50 records, severity classification shows 6 critical, 43 moderate, and 1 lower-severity recalls. The page references 26 distinct recalling firms operating in 5 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (42), NHTSA (5), CPSC (3), 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 2021 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 Aug 25, 2021

Trilogy Evo Universal, Product number DS2000X11B

Philips Respironics, Inc.

FDA Devices Moderate Aug 25, 2021

Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19…

Philips Respironics, Inc.

FDA Devices Moderate Aug 25, 2021

TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

Boston Scientific Corporation

FDA Devices Moderate Aug 25, 2021

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: …

W L Gore & Associates, Inc.

FDA Devices Moderate Aug 25, 2021

728333 Spectral CT 7500 -Computed Tomography X-ray system

Philips North America Llc

FDA Devices Moderate Aug 25, 2021

728332 IQon Spectral CT-Computed Tomography X-ray system

Philips North America Llc

FDA Devices Moderate Aug 25, 2021

NEO DELTA Self Safe, I.V. Catheter REF 3738222

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

728327 Ingenuity CT Upgrades-Computed Tomography X-ray system

Philips North America Llc

FDA Devices Moderate Aug 25, 2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter:

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

Philips North America Llc

FDA Devices Moderate Aug 25, 2021

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 …

Teleflex Medical Europe Ltd

FDA Devices Moderate Aug 25, 2021

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

Epimed International

FDA Devices Moderate Aug 25, 2021

OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

OPTI Medical Systems, Inc

FDA Devices Moderate Aug 25, 2021

RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065…

Teleflex Medical Europe Ltd

FDA Devices Critical Aug 25, 2021

Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) …

Cardinal Health 200, LLC

FDA Devices Moderate Aug 25, 2021

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) R…

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

Cytocell Ltd.

FDA Devices Moderate Aug 25, 2021

The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW…

Tornier S.A.S.

FDA Devices Low Aug 25, 2021

Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

Cell Marque Corporation

FDA Devices Moderate Aug 25, 2021

RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e)…

Teleflex Medical Europe Ltd

FDA Devices Moderate Aug 25, 2021

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: …

W L Gore & Associates, Inc.

FDA Devices Moderate Aug 25, 2021

Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B

Philips Respironics, Inc.

FDA Devices Moderate Aug 25, 2021

Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures

Hitachi Healthcare Americas Corporation

FDA Devices Moderate Aug 25, 2021

NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile

Epimed International

FDA Devices Moderate Aug 25, 2021

RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 5045…

Teleflex Medical Europe Ltd

FDA Devices Moderate Aug 25, 2021

DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, …

Olympus Corporation of the Americas

FDA Devices Moderate Aug 25, 2021

Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

Howmedica Osteonics Corp.

FDA Devices Moderate Aug 25, 2021

EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi

Philips Ultrasound Inc

FDA Devices Moderate Aug 25, 2021

Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system

Philips North America Llc

FDA Devices Moderate Aug 25, 2021

FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

Ostial Corporation

FDA Devices Moderate Aug 25, 2021

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

Boston Scientific Corporation

FDA Devices Moderate Aug 25, 2021

DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 …

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple o…

Ethicon Endo-Surgery Inc

FDA Devices Moderate Aug 25, 2021

Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator …

CooperSurgical, Inc.

FDA Devices Moderate Aug 25, 2021

Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, I…

Philips Respironics, Inc.

FDA Devices Moderate Aug 25, 2021

EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile

Ortho8, Inc.

CPSC Moderate Aug 25, 2021

Razor USA Recalls GLW Battery Packs Sold with Hovertrax 2.0 Self-Balancing Hoverboards Due to Fire Hazard

CPSC Moderate Aug 25, 2021

Wee Gallery Recalls Wooden Tray Puzzles Due to Choking Hazard

NHTSA Critical Aug 23, 2021

FORD 2021: SEAT BELTS:FRONT:WEBBING

FORD

NHTSA Critical Aug 23, 2021

FORD,LINCOLN 2021: AIR BAGS:SIDE/WINDOW:CURTAIN

FORD,LINCOLN

NHTSA Critical Aug 20, 2021

VOLKSWAGEN 2022: FUEL SYSTEM, GASOLINE:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS

VOLKSWAGEN

NHTSA Critical Aug 20, 2021

CHEVROLET 2020-2022: ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY

CHEVROLET

NHTSA Critical Aug 20, 2021

CADILLAC,CHEVROLET 2016-2021: SEAT BELTS:CRITICAL FASTENERS

CADILLAC,CHEVROLET

CPSC Moderate Aug 19, 2021

Infant Bath Seats Recalled Due to Drowning Hazard; Imported by Frieyss and Sold Exclusively on Amazon.com (Recall Alert)

Qingdao Ruizexin Electronic Technology Co. Ltd., of China

Nearby Recall Years

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

Compare 2021 with 2020 →

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 2021

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2021 across the FDA, CPSC and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.