Product category · Updated Mar 18, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Category snapshot
Medical Devices accounts for 27,372 recalls — about 32.6% of the 83,949-record federal archive, with 2,343 graded high-severity, most issued by FDA Devices.
- 27,372
- 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 2,343
High severity
2,343 recalls
- Moderate
Moderate
24,310 recalls
- Lower severity 719
Lower severity
719 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
26,000 recalls
- FDA Drug 880
FDA Drug
880 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 51
FDA Food
51 recalls
Recalls in Medical Devices
Newest first · Page 1 of 548
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Waldemar Link GmbH & Co. KG (Mfg Site)
Penner Pacific Bathing Spa, Model Numbers 360020-1P
Penner Patient Care, Inc.
GEM Premier 5000 PAK, Part No. 00055360004.
Instrumentation Laboratory
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Beckman Coulter Mishima K.K.
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Met…
Trividia Health, Inc.
Artelon FlexBand Dynamic Matrix Ref: 31057
International Life Sciences
GEM Premier 5000; Part No. 00055415005.
Instrumentation Laboratory
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Waldemar Link GmbH & Co. KG (Mfg Site)
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.
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Waldemar Link GmbH & Co. KG (Mfg Site)
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobi…
Raz Design Inc
GEM Premier 5000; Model No. 00055430010.
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430008.
Instrumentation Laboratory
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Waldemar Link GmbH & Co. KG (Mfg Site)
GEM Premier 5000; Part No. 00055415008.
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407511.
Instrumentation Laboratory
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Num…
Medline Industries, LP
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Exactech, Inc.
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 36…
Penner Patient Care, Inc.
GEM Premier 5000 PAK; Part No. 00055360011.
Instrumentation Laboratory
DxC 700 AU, REF: B86444, B86446
Beckman Coulter Mishima K.K.
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
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
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 Mar 18, 2026.
Read our methodology — how this data is sourced, computed, and verified.
