Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 recalls
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 15 of 808
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11…
Physio-Control, Inc.
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product De…
Medartis AG
GEM Premier 5000 PAK; Part No. 00055407508.
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445008.
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407510.
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360008.
Instrumentation Laboratory
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX…
Trividia Health, Inc.
GEM Premier 5000; Part No. 00055445004.
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415010.
Instrumentation Laboratory
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
International Life Sciences
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
KOB GmbH
Artelon FlexBand Plus Ref: 41054 & 41057
International Life Sciences
GEM Premier 5000; Part No. 00055430004.
Instrumentation Laboratory
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
Penner Patient Care, Inc.
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vita…
Covidien LLC
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 37000…
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A…
Penner Patient Care, Inc.
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Waldemar Link GmbH & Co. KG (Mfg Site)
Penner Pacific Bathing Spa, Model Numbers 860010-1L
Penner Patient Care, Inc.
GEM Premier 5000; Part No: 00055415011.
Instrumentation Laboratory
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Penner Patient Care, Inc.
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Altruan GmbH
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Becton Dickinson & Company
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRI…
Trividia Health, Inc.
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Exactech, Inc.
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Penner Patient Care, Inc.
IBA Proton Therapy System - PROTEUS 235
Ion Beam Applications S.A.
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Waldemar Link GmbH & Co. KG (Mfg Site)
GEM Premier 5000; Part No. 00055430011.
Instrumentation Laboratory
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4J…
Medline Industries, LP
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Waldemar Link GmbH & Co. KG (Mfg Site)
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN D…
Medline Industries, LP
CLARITY II Laser System; Model No. 1110200210.
Lutronic Corporation
GEM Premier 5000 PAK; Part No. 00055360010.
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055415004.
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445010 & 00055445011.
Instrumentation Laboratory
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Waldemar Link GmbH & Co. KG (Mfg Site)
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product De…
Medartis AG
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Altruan GmbH
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Penner Patient Care, Inc.
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Waldemar Link GmbH & Co. KG (Mfg Site)
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Altruan GmbH
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Boston Scientific Corporation
GEM Premier 5000 PAK; Part No. 00055407504.
Instrumentation Laboratory
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Waldemar Link GmbH & Co. KG (Mfg Site)
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument c…
Olympus Corporation of the Americas
Impella RP Flex with SmartAssist. Product Code: 1000323.
Abiomed, Inc.
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jul 2, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 2, 2026.