PlainRecalls

2021 Recalls

4,225 recalls · Page 57 of 85

2021 Recall Year Insight

Federal agencies issued 4,225 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.03% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 11.6 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 85 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 1 critical, 46 moderate, and 3 lower-severity recalls. The page references 15 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 (41), FDA Drug (9), 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, 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 26, 2021

Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04

Teva Pharmaceuticals USA

FDA Drug Moderate May 26, 2021

Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA …

Teva Pharmaceuticals USA

FDA Drug Moderate May 26, 2021

PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

Hyobin LLC

FDA Drug Low May 26, 2021

Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10

SigmaPharm Laboratories LLC

FDA Drug Low May 26, 2021

Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940…

KVK-Tech, Inc.

FDA Drug Moderate May 26, 2021

Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19…

Teva Pharmaceuticals USA

FDA Drug Moderate May 26, 2021

Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest,…

Pfizer Inc.

FDA Drug Low May 26, 2021

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun P…

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate May 26, 2021

Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Lab…

Preferred Pharmaceuticals, Inc.

FDA Devices Moderate May 26, 2021

BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN:…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

Bioseal Corporation

FDA Devices Moderate May 26, 2021

CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 007630003…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 0076300…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 20763000…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use …

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when c…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 …

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 2076300033…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when ce…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 0076300024…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when c…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)108…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035989…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

Bioseal Corporation

FDA Devices Moderate May 26, 2021

8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)1080174114752…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

Roche Diagnostics Operations, Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 007630003…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for …

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

10 GAUGE DRILL, CODE INTVM-DRL

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: intende…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

RAYSEARCH LABORATORIES AB

FDA Devices Moderate May 26, 2021

REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035996 …

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: intended for…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK

BIOPSYBELL S.R.L.

FDA Devices Critical May 26, 2021

VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.

Boston Scientific Corporation

FDA Devices Moderate May 26, 2021

Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve …

WillowWood Global Llc

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: intended for use…

Medtronic Inc.

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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2021