PlainRecalls

2021 Recalls

4,225 recalls · Page 34 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 14 critical, 36 moderate, and 0 lower-severity recalls. The page references 18 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 (39), FDA Drug (11), 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 Critical Aug 18, 2021

MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML…

Med Shop Total Care Inc.

FDA Drug Moderate Aug 18, 2021

Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

FDA Drug Critical Aug 18, 2021

BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Med Shop Total Care Inc.

FDA Drug Critical Aug 18, 2021

HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-…

Med Shop Total Care Inc.

FDA Drug Moderate Aug 18, 2021

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz…

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

FDA Drug Critical Aug 18, 2021

C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN …

People's Custom Rx and Clinical Care, LLC

FDA Drug Critical Aug 18, 2021

MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Med Shop Total Care Inc.

FDA Drug Critical Aug 18, 2021

MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 4…

Med Shop Total Care Inc.

FDA Drug Critical Aug 18, 2021

SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Med Shop Total Care Inc.

FDA Drug Critical Aug 18, 2021

HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview…

Med Shop Total Care Inc.

FDA Drug Critical Aug 18, 2021

FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 7…

Med Shop Total Care Inc.

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Implant Kit, REF 1125

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 11050000…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used thro…

Shent USA, Inc.

FDA Devices Moderate Aug 18, 2021

Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿27…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis sc…

Abbott Laboratories, Inc

FDA Devices Moderate Aug 18, 2021

MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and…

BioMerieux SA

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working …

Shent USA, Inc.

FDA Devices Moderate Aug 18, 2021

Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Medline Industries Inc

FDA Devices Moderate Aug 18, 2021

Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platfor…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspira…

Bard Peripheral Vascular Inc

FDA Devices Moderate Aug 18, 2021

Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical trea…

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Implant Kit, REF 1153

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3…

Stryker Medical Division of Stryker Corporation

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Outflow Graft, REF MCS1725OG

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model …

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surg…

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

Exactech, Inc.

FDA Devices Moderate Aug 18, 2021

Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.

Exactech, Inc.

FDA Devices Moderate Aug 18, 2021

ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;

Beckman Coulter Inc.

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Accessories, REF MCS1753AK

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (…

Edwards Lifesciences, LLC

FDA Devices Moderate Aug 18, 2021

The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

Dutch Ophthalmic USA, Inc.

FDA Devices Moderate Aug 18, 2021

ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017

Beckman Coulter Inc.

FDA Devices Moderate Aug 18, 2021

S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Medline Industries Inc

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331

Biomet, Inc.

FDA Devices Critical Aug 18, 2021

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

Baxter Healthcare Corporation

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewir…

Edwards Lifesciences, LLC

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidew…

Edwards Lifesciences, LLC

FDA Devices Moderate Aug 18, 2021

Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm

Bard Peripheral Vascular Inc

FDA Devices Moderate Aug 18, 2021

Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For t…

Merit Medical Systems, 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