Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- 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 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 recalls
Recalls in Medical Devices
Newest first · Page 15 of 810
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.
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument…
Olympus Corporation of the Americas
Impella RP with SmartAssist. Product Code: 0046-0035.
Abiomed, Inc.
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Descri…
Olympus Corporation of the Americas
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed …
B Braun Medical Inc
Impella RP. Product Code: 0046-0011.
Abiomed, Inc.
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Staar Surgical AG
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description…
Aesculap 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 Jun 3, 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 Jun 3, 2026.