Hazard

Device Defect recalls

184 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

151–175 of 184

HighFDA (Devices)·Z-1051-2023·2023-02-08
Bard Catheter Repair Kits Recalled for Hardened, Unusable Adhesive
Bard Peripheral Vascular is recalling multiple catheter repair kits because the adhesive may be hardened or coagulated, rendering the kits unusable. Approximately 7,520 units were distributed worldwide.
Product
Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all ex
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0670-2023·2022-12-21
Surgical Spinal Fusion Device Recalled Across 23 US States
DeRoyal is recalling its Posterior Lumbar Fusion Pack medical device across 23 states. The voluntary recall affects specific lot numbers; patients should consult their healthcare provider.
Product
DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0633-2023·2022-12-21
DeRoyal Laminectomy Spinal Fusion Pack Recalled by FDA (Class II)
DeRoyal Industries voluntarily recalled 100 kits of its laminectomy spinal fusion pack after identifying a device defect. The recall affects medical facilities in 23 states.
Product
DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0692-2023·2022-12-21
FDA Class II Recall of DeRoyal Posterior Spine Surgical Packs
DeRoyal Industries voluntarily recalled 1,196 posterior spine surgical packs distributed across 23 states. The specific reason for the recall was not documented.
Product
DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0667-2023·2022-12-21
DeRoyal ACDF surgical implant kit recall, Class II, reason undisclosed
DeRoyal is recalling 63 ACDF surgical implant kits distributed to 23 US states. This is a voluntary, Class II recall announced November 2022, with no reported illnesses or injuries.
Product
DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0677-2023·2022-12-21
FDA recalls DeRoyal CRANI PACK medical device over defect
The FDA has recalled DeRoyal CRANI PACK devices (Lot 57389117, expiring 9/1/2026) due to a device defect. The recall affects 16 kits distributed across 23 US states.
Product
DeRoyal CRANI PACK, REF 89-10202.05
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0689-2023·2022-12-21
Medical Device Recall: DeRoyal CNRV Peripheral VAS Pack
DeRoyal Industries is recalling 68 kits of the CNRV Peripheral VAS Pack. The voluntary Class II recall affects healthcare facilities in 23 US states with specific lot numbers.
Product
DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0585-2023·2022-12-21
Medical Device Recall: DeRoyal GU Robotic Pack, 192 Kits
DeRoyal Industries has recalled 192 kits of the DeRoyal GU Robotic Pack (Lot 57387066, expires 9/1/2026) distributed across 23 U.S. states. The FDA classified this as a Class II recall.
Product
DeRoyal GU ROBOTIC PACK, REF 89-7063.12
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0696-2023·2022-12-21
FDA Medical Device Recall: DeRoyal GU Pack genitourinary kits
DeRoyal Industries initiated a voluntary recall of 75 genitourinary (GU) pack kits (Lot 55971461, exp. 5/1/2024). The specific reason for recall is not disclosed in available FDA documentation.
Product
DeRoyal GU PACK, REF 89-10665.02
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0602-2023·2022-12-21
DeRoyal Endovenous Procedure Packs Recalled Due to Affected Steri Drapes
DeRoyal is recalling 88 endovenous procedure packs containing 3M Health Care Steri Drapes that have been recalled. The packs were distributed across 23 US states; consumers should stop using them immediately.
Product
DeRoyal ENDOVENOUS PACK, REF 89-7762.05
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0656-2023·2022-12-21
FDA Recalls DeRoyal Shoulder Kit Medical Device across 23 states
DeRoyal Industries recalled 28 SHOULDER KIT units due to an unspecified Class II device defect. The affected lot numbers were distributed across 23 U.S. states between November 2022 and April 2025.
Product
DeRoyal SHOULDER KIT, REF 89-9497.10
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0575-2023·2022-12-21
DeRoyal shoulder procedure packs recalled for defective 3M Steri Drapes
DeRoyal OPEN SHOULDER PROCEDURE PACK RF kits are being recalled because they contain 3M Health Care Steri Drapes that have been subject to recall. A total of 42 kits are affected.
Product
DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0622-2023·2022-12-21
FDA Class II Medical Device Recall: GEO-MED Biopsy Tray
DeRoyal Industries Inc voluntarily recalled approximately 460 units of GEO-MED BIOPSY TRAY distributed across 23 US states. The specific reason for the recall is not disclosed in available FDA documentation.
Product
GEO-MED BIOPSY TRAY, REF 89-8753.01
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0604-2023·2022-12-21
GEO-MED Lower Extremity Procedure Packs Recalled Due to Defective 3M Steri Drapes
DeRoyal Industries is recalling 48 kits of GEO-MED Lower Extremity Packs because they contain 3M Health Care Steri Drapes that have been recalled. The affected kits were distributed to healthcare facilities across the United States.
Product
GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0631-2023·2022-12-21
DeRoyal Laminectomy Spinal Fusion Surgical Pack Recall (Class II)
DeRoyal Industries is recalling 180 kits of laminectomy spinal fusion surgical packs distributed across 23 states. The reason for recall is not specified in the available source.
Product
DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0288-2023·2022-11-30
Surgical Convenience Kits Recalled Due to Defective 3M Surgical Drapes
ROi CPS LLC is recalling regard BASIC NEURO surgical convenience kits containing 3M surgical drapes that were previously recalled. Affected units were distributed to LA, MO, NC, and FL.
Product
regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0302-2023·2022-11-30
Surgical Convenience Kits with Recalled 3M Surgical Drapes
ROi CPS LLC is recalling 21 surgical convenience kits distributed to Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that were subsequently recalled.
Product
regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1776-2022·2022-09-28
FDA Recalls Grappler Suture Anchors Due to Potential Breakage Risk
Paragon 28, Inc. is recalling Grappler Suture Anchors (REF: P44-110-3010-SK, Lot 5007499) due to risk that the anchor may break upon insertion, potentially leaving debris in patients and delaying surgery.
Product
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1685-2022·2022-09-14
MEGA Intra-Aortic Balloon Catheter Recalled for Undersized Dilator
Datascope Corporation is recalling 10,427 units of the MEGA 8Fr 50cc Intra-Aortic Balloon Catheter due to an undersized dilator in certain lots. The device has been distributed internationally and is awaiting domestic distribution.
Product
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1320-2022·2022-07-13
Dialysis Catheters Recalled for Potential Fluid Leakage from Hub Defect
Covidien is recalling Mahurkar Chronic Carbothane dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use. Approximately 132,443 units distributed worldwide are affected.
Product
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1315-2022·2022-07-13
Palindrome Precision Chronic Dialysis Catheters Risk Fluid Leakage Due to Hub Defect
Covidien recalls 25,765 Palindrome Precision HSI Chronic Catheters due to a defect in the hub that may cause unintended fluid leakage during dialysis treatment.
Product
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1273-2022·2022-06-29
FDA Recalls Catheter Drainage Kits With Wrong Needle Size
Bard Peripheral Vascular Inc is recalling certain catheter drainage kits that may contain an 8 Fr needle instead of the correct 6 Fr needle. The incorrect needle size could cause tissue injury during patient care.
Product
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1240-2022·2022-06-15
Hilal Embolization Microcoils Recalled for Unintended Stainless-Steel Cannula
Cook Incorporated is recalling Hilal Embolization Microcoils because their loading cartridges may contain an unintended stainless-steel cannula. The recall affects 106,033 units distributed nationwide and internationally.
Product
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0571-2022·2022-02-16
Baxter MiniCap PD Transfer Sets Recalled for Chemical Damage Risk
Baxter Healthcare is recalling 2,553,528 units of the MiniCap Extended Life PD Transfer Set worldwide because cleaning products containing certain chemicals may cause the device to leak or crack.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0106-2022·2021-10-20
Ion Flexison Biopsy Needle recalled for potential sheath tip separation
Intuitive Surgical recalled 1,625 Ion Flexison Biopsy Needles due to potential sheath tip separation from the shaft. Affected units are distributed across 29 US states and China; no injuries have been reported.
Product
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Category
Medical Device
Distribution
26 states