PlainRecalls

2022 Recalls

Compiled from official public sources by the editorial team.

5,888 recalls · Page 4 of 118

2022 Recall Year Insight

Federal agencies issued 5,888 product recalls indexed by PlainRecalls in calendar year 2022. That represents about 5.79% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 16.1 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 118 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 2022.

On this page of 50 records, severity classification shows 5 critical, 45 moderate, and 0 lower-severity recalls. The page references 7 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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 2022 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 Critical Dec 21, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

CarePoint 60 mL Syringe Without Needle, REF: 04-7560

Allison Medical, Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal EYE TRAY, REF 89-4957.08

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal SPINAL FUSION PACK, REF 89-7515.12

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal CUSTOM NEURO PACK, REF 89-7353.17

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

Zimmer, Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal CATARACT PACK, REF 89-9241.04

DeRoyal Industries Inc

FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal CRANI PACK, REF 89-10202.03

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02

Zimmer, Inc.

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Endo Pack, Item No.682-509,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal LAPINECTOMY PACK, REF 89-7198.11

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal TOTAL HIP PACK, REF 89-9113.06

DeRoyal Industries Inc

FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 21, 2022

DeRoyal TOTAL HIP PACK, REF 89-9113.07

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal PACEMAKER ICD PACK, REF 89-10902.01

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal SPINE PACK, REF 89-8361.08

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal KIT TOTAL HIP, REF 89-8861.07

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal CRANI PACK, REF 89-10202.05

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, CATH PACK Item No.570-2789

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02

Zimmer, Inc.

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, OMFS, Item No.570-2779,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Vein, Item No.682-1732,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal LUMBAR DISC PACK, REF 89-10590.02

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal SPINE PACK, REF 89-8361.09

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal UNIVERSAL PACK, REF 89-9558.03

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Critical Dec 21, 2022

Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal CATARACT PACK, REF 89-9241.03

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

Leica Microsystems, Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal BIOPSY PACKPACK, REF 89-9756.05

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

STRADIS HEALTHCARE, Vein, Item No.682-577,

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal LUMBAR DISC PACK, REF 89-10605.02

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal PORT PACK PGYBK, REF 89-8748.05

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07

DeRoyal Industries Inc

FDA Devices Critical Dec 21, 2022

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal LUMBAR FUSION PACK, REF 89-10211.05

DeRoyal Industries Inc

Nearby Recall Years

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

Compare 2022 with 2021 →

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 2022

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 2022 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.