State

Massachusetts product recalls

73,388 recalls have nationwide distribution and so reach Massachusetts. 8,241 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total: 8,241
Critical: 1,181
Severe: 2,353
Most recent: 2026-10-07

Of the 8,241 recalls naming Massachusetts we have scored against our rubric, 1,181 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,353 (29%) are Severe.

Which agencies issued them

These figures cover only the 8,241 recalls whose distribution notice names Massachusetts specifically. The 73,388 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

19751–19775 of 81629

HighFDA (Devices)·Z-0474-2023·2022-12-21
Electrosurgical Suction Coagulator Devices Recalled Due to Potential Suction Port Blockage
ConMed's electrosurgical suction coagulator devices may have blocked suction ports that prevent proper function during procedures. Affected devices could cause procedure delays and require alternative equipment.
Product
Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0626-2023·2022-12-21
DeRoyal TLIF Procedure Packs Recalled Due to Included 3M Steri Drapes
DeRoyal TLIF procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The affected packs were distributed across multiple U.S. states.
Product
DeRoyal TLIF PACK, REF 89-8780.04
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0516-2023·2022-12-21
Stradis Healthcare Major Extremity Surgical Kits Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Henry Schein Major Extremity surgical kits due to incomplete outer bag sealing that could compromise kit sterility. Affected kits were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0686-2023·2022-12-21
Medical Device Recall: DeRoyal HAND PACK Kit Lot 57685848
DeRoyal Industries Inc is voluntarily recalling DeRoyal HAND PACK kits (Lot 57685848) distributed across 23 US states. The reason for recall has not been publicly disclosed.
Product
DeRoyal HAND PACK, REF 89-10314.03
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0720-2023·2022-12-21
Cordis Angiographic Catheter Extensions Recalled for Male Connector Separation Risk
Cordis angiographic catheter extensions may experience separation at the male connector during use. Approximately 2,915 US units were distributed; users should verify affected lot numbers.
Product
Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0475-2023·2022-12-21
Surgical microscope power supply may overheat and cause unexpected shutdown
Leica Microsystems is recalling 43 Proveo 8 surgical microscopes nationwide due to a potential power supply defect that may cause device overheating and unexpected shutdown during use.
Product
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0506-2023·2022-12-21
General Surgery Procedure Kit Recalled for Sterility Concerns
Stradis Medical is recalling surgical procedure kits with potentially incomplete outer bag seals that may compromise sterility. The recall affects 35 units distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0560-2023·2022-12-21
DeRoyal Minor Oral and ENT Procedure Packs Recalled for Defective Steri Drapes
DeRoyal procedure packs distributed across multiple U.S. states are being recalled because they contain previously recalled 3M Steri Drapes. Affected healthcare facilities should stop using the packs and contact the manufacturer.
Product
DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
Category
Medical Device
Distribution
23 states
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
23 states
HighFDA (Devices)·Z-0607-2023·2022-12-21
FDA Recalls DeRoyal BASIC EYE PACK Medical Device Kits
The FDA has issued a recall of 50 kits of DeRoyal BASIC EYE PACK, a medical device distributed across 23 U.S. states. The specific reason for the recall is not provided in available source information.
Product
DeRoyal BASIC EYE PACK, REF 89-8337.09
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0574-2023·2022-12-21
FDA Class II recall: DeRoyal surgical procedure pack distributed to multiple states
DeRoyal Industries voluntarily recalled 3 kits of its OPEN SHOULDER PROCEDURE PACK RF (Lot 56391733, expiring 3/1/2024) starting November 2022. The recall affects multiple U.S. states.
Product
DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0530-2023·2022-12-21
Single-shot epidural kits recalled due to incomplete outer bag sealing
Stradis Medical is recalling 80 Henry Schein single-shot epidural kits due to potentially incomplete outer bag sealing that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0538-2023·2022-12-21
Stradis Healthcare Thoracic Surgery Kits Recalled for Sterility Risk
Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.
Product
STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0514-2023·2022-12-21
ENT Surgical Kits Recalled for Potential Sterility Loss
Stradis Medical is recalling HENRY SCHEIN ENT surgical kits distributed nationwide due to defective outer bag sealing that may compromise sterility. Affected kits were distributed across the US and Canada.
Product
HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742
Category
Medical Device
Distribution
Distributed nationwide
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
23 states
HighFDA (Devices)·Z-0493-2023·2022-12-21
Stradis Healthcare Dental Implant Trays Recalled Due to Incomplete Sealing
Stradis Healthcare is recalling dental implant trays with incomplete outer bag seals that may compromise sterility. Affected units were distributed in the US and Canada.
Product
STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0597-2023·2022-12-21
DeRoyal Spinal Fusion Packs Recalled for Containing Affected 3M Steri Drapes
DeRoyal procedure kits for spinal fusion are being recalled because they contain 3M Health Care Steri Drapes that have been recalled by 3M. The affected 16 kits were distributed to healthcare facilities in 23 US states.
Product
DeRoyal SPINAL FUSION PACK, REF 89-7515.13
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0508-2023·2022-12-21
Surgical Procedure Trays Recalled for Potential Sterility Breach
Stradis Medical recalls surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. The affected products were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, Basin Set, Item No.570-1803
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0548-2023·2022-12-21
Stradis Healthcare Surgical Procedure Kits Recalled for Incomplete Sealing
Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.
Product
STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0676-2023·2022-12-21
Medical Device Kit Recall: DeRoyal CRANI PACK Lot 56705261
DeRoyal Industries is recalling 16 units of the DeRoyal CRANI PACK (Lot 56705261, expiring 6/1/2025) distributed across multiple U.S. states. The specific reason for this Class II recall is not disclosed in the source notice.
Product
DeRoyal CRANI PACK, REF 89-10202.03
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0649-2023·2022-12-21
DeRoyal Endovascular Tracepack Medical Device Recall, FDA Class II
DeRoyal Industries initiated a Class II recall of 495 endovascular tracepack kits distributed across 23 U.S. states due to an unspecified manufacturing concern.
Product
DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0650-2023·2022-12-21
Medical Device Shoulder Pack Recall Initiated by Manufacturer
DeRoyal Industries initiated a voluntary recall of 32 kits of its Shoulder Pack medical device distributed across 23 U.S. states. The specific reason for the recall was not provided in the source documentation.
Product
DeRoyal SHOULDER PACK, REF 89-9449.12
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0620-2023·2022-12-21
FDA Recalls GEO-MED Podiatry Pack Medical Device Kit
DeRoyal Industries voluntarily recalls GEO-MED Podiatry Pack medical device kits distributed across 23 US states. The specific reason for recall is not detailed in available source materials.
Product
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0663-2023·2022-12-21
Medical Device Recall: DeRoyal Breast Augmentation Pack Class II
DeRoyal Industries initiated a voluntary Class II recall of 70 kits of its Breast Augmentation Pack distributed across 23 US states. The specific reason for the recall is not stated in available FDA materials.
Product
DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-0577-2023·2022-12-21
GEO-MED PLASTIC HAND PACK RF Medical Device Recall
DeRoyal Industries Inc is recalling 102 kits of the GEO-MED PLASTIC HAND PACK RF. The reason for the recall is not publicly specified. The recall affects 23 US states and was voluntarily initiated by the manufacturer.
Product
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
Category
Medical Device
Distribution
23 states