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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 201–220 of 1,000 recalls

Class IIOngoing

GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
Class IIOngoing

Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15

Cardinal Health 200, LLC

The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.

August 10, 2026 · DeviceView details →
Class IIOngoing

MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
Class IIOngoing

5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C

Fresenius Medical Care Renal Therapies Group, LLC

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

August 10, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A; 4) MAJOR NEURO PACK, Catalog Number: DYNJ57233J; 5) NEURO, Catalog Number: DYNJ82388A; 6) NEURO PACK, Catalog Number: DYNJ86656; 7) NEURO ACD, Catalog Number: DYNJ904549G

Medline Industries, LP

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

August 10, 2026 · DeviceView details →
Class IIOngoing

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO

American Contract Systems Inc

Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).

August 10, 2026 · DeviceView details →
Class IIOngoing

DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.

Medline Industries, LP

Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.

August 10, 2026 · DeviceView details →
Class IIOngoing

ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
Class IIOngoing

LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348S; 5) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348T

Medline Industries, LP

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

August 10, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ40094G; 4) ENT PACK, Catalog Number: DYNJ50699F; 5) EENT PACK, Catalog Number: DYNJ83219

Medline Industries, LP

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

August 10, 2026 · DeviceView details →
Class IIOngoing

PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A

Medline Industries, LP

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

August 10, 2026 · DeviceView details →
Class IIOngoing

HEART PREP TRAY; Model/Item Number (Kit): MECV97W;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
Class IIOngoing

PLASTICS TRAY; Model/Item Number (Kit): EURO053;

AVID Medical, Inc.

Product may be potentially contaminated with a lubricant used during the manufacturing process.

August 10, 2026 · DeviceView details →
Class IIOngoing

Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x

Philips North America Llc

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

August 7, 2026 · DeviceView details →
Class IIOngoing

Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110

Happiest Baby, Inc

Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

August 7, 2026 · DeviceView details →
Class IIOngoing

Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x

Philips North America Llc

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

August 7, 2026 · DeviceView details →
Class IIOngoing

Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);

Atrium Medical Corporation

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

August 7, 2026 · DeviceView details →
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